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Nitinol heat-setting fixture for Boston Scientific WATCHMAN FLX machined for Maple Grove structural heart supplier 316L stainless stent laser-cutting fixture die machined for Boston Scientific coronary stent programs
ISO 13485:2016 & FDA 21 CFR 820-Aligned · Boston Scientific Supplier

CNC Machining in
Maple Grove, MN

Boston Scientific's WATCHMAN FLX and coronary stent programs in Maple Grove demand cardiovascular-grade tooling — not job-shop tolerances. We machine nitinol expansion mandrels (ASTM F2063), 316L stent laser-cutting dies (±0.0003"), Co-Cr L-605 crimping mandrels, and PEEK catheter hubs. ISO 13485-aligned documentation, cleanroom packaging, 3-day LTL to 55369.

Securely upload your 3D CAD file. ISO 13485-aligned handling for cardiovascular device tooling; NDA and Boston Scientific Supplier Quality Agreement documentation available on request.

2020
WATCHMAN FLX FDA approval
for LAA closure in nonvalvular AFib
100K+ patients treated worldwide
±0.0005"
Nitinol expansion mandrel OD
for WATCHMAN FLX frame tooling
ASTM F2063 UNS N01555
±0.0003"
Stent laser-cutting fixture
die geometry tolerance
316L ASTM F138, coronary stent tooling
3 day
Union City, CA to 55369
standard LTL via I-94/I-90
SFO/OAK → MSP next-day air

Maple Grove Is the Structural Heart Corridor of America's Medical Alley

Maple Grove is not a city with a cardiac device cluster — Maple Grove is structural heart manufacturing. Boston Scientific chose Maple Grove for its structural heart and coronary intervention manufacturing operations, anchoring the WATCHMAN FLX left atrial appendage (LAA) closure program and coronary stent tooling — the PROMUS Premier, Synergy, and REBEL platforms that treat millions of AFib and CAD patients worldwide. The WATCHMAN FLX received FDA approval in 2020 for LAA closure in nonvalvular atrial fibrillation patients, and the 100K+ patient milestone demonstrates the manufacturing scale Boston Scientific has built in this ZIP code. Pairing with Plymouth's Medtronic CRM corridor six miles to the southeast, Maple Grove and Plymouth together form the world's densest cardiovascular implant engineering corridor. Around the Boston Scientific anchor sit Cardiovascular Systems Inc. (CSI) with its orbital atherectomy systems, SurModics with its surface modification and drug-delivery coating technology, and Upsher-Smith Laboratories at 6701 Evenstad Dr on the Plymouth/Maple Grove border. RivCut machines the tooling, fixturing, and precision hardware that make these cardiovascular programs possible — not the implants themselves, but the mandrels, dies, fixtures, and gauges the engineers need to build and inspect them.

1

Boston Scientific-Flavored Documentation

ISO 13485:2016 QMS, FDA 21 CFR 820 QSR, ISO 14971 risk management, ISO 25539 cardiovascular implant standards. Boston Scientific Supplier Quality Manual flow-downs, BSCI supplier qualification documentation, signed Supplier Quality Agreement, and full ASTM material traceability per F2063 (nitinol), F138 (316L), F90 (Co-Cr L-605), F899 (17-4 PH), and F2026 (PEEK).

2

Cardiovascular-Grade Materials

Nitinol (ASTM F2063 UNS N01555) heat-setting fixture tooling, 316L SS (ASTM F138) stent dies, Cobalt-Chromium L-605 (ASTM F90) mandrels, 17-4 PH (ASTM F899) delivery system components, Ti-6Al-4V (ASTM F1472) structural parts, and PEEK (ASTM F2026) catheter hub components. EN 10204 3.1 mill test reports traceable to heat and lot on every shipment.

3

I-94/I-90 Ship-to-Maple-Grove

3-day standard LTL from Union City, CA to 55369 via the I-94/I-90 corridor into MSP. SFO/OAK → MSP daily on Delta and UPS 2A for urgent cardiovascular tooling orders. Parts ship double-bagged in ISO Class 7 (Class 10,000) cleanroom packaging with validated ASTM A967 passivation and full mill certs.

Tooling and Fixturing for Boston Scientific and the Cardiovascular Supply Chain

From WATCHMAN FLX expansion mandrels to stent laser-cutting fixture dies and Co-Cr crimping tooling — Maple Grove work demands sub-0.001" feature tolerances, ASTM cardiovascular material standards, ISO 13485-grade documentation, and schedules that hit Boston Scientific program milestones.

WATCHMAN Frame Expansion Mandrels

Nitinol heat-setting fixture tooling and WATCHMAN FLX frame expansion mandrel sets held to ±0.0005" OD — driven by the shape-memory transformation temperature sensitivity unique to LAA closure device manufacturing. 316L (ASTM F138) and 17-4 PH (ASTM F899) tooling steel bodies with Zeiss CMM reports and ASTM F2063 nitinol material traceability.

Nitinol ASTM F2063, WATCHMAN FLX

Stent Laser-Cutting Fixture Dies

Coronary stent laser-cutting fixture dies in 316L stainless per ASTM F138 at ±0.0003" die geometry tolerance for PROMUS Premier, Synergy, and REBEL stent programs. 5-axis milling with diamond-point finishing passes, Zeiss CMM dimensional verification, ASTM A967 passivation, and full lot traceability for the Boston Scientific stent manufacturing line.

316L ASTM F138, ±0.0003" die geometry

PEEK Catheter Hub Components

Implant-grade PEEK per ASTM F2026 machined catheter hub components, luer fittings, and strain-relief bodies for WATCHMAN FLX delivery systems and coronary intervention catheters. Dedicated polymer lines, diamond-coated tooling, double-bagged ISO Class 7 packaging, and full lot traceability. Hub bores held to ±0.001" for delivery system mechanical fit.

PEEK ASTM F2026, hub bore ±0.001"

Co-Cr L-605 Stent Mandrels & Crimping Tooling

Cobalt-chromium L-605 per ASTM F90 stent expansion mandrels and crimping tooling for Boston Scientific coronary stent programs. Co-Cr L-605 work-hardening demands coated carbide and ceramic tooling on rigid 5-axis centers — we hold stent mandrel geometry and deliver Zeiss CMM reports with ASTM F3057 and EN 10204 3.1 mill test reports.

Co-Cr L-605 ASTM F90, ASTM F3057

Inspection Gauges & CMM Fixtures

Precision inspection gauges and CMM holding fixtures for WATCHMAN FLX frame geometry verification and coronary stent dimensional inspection. Machined in 316L and hardened tool steel with Zeiss CMM calibration certification, NIST-traceable gauging, and Boston Scientific quality system-compatible documentation packages.

Inspection gauges, CMM fixtures

17-4 PH Delivery System Parts

17-4 PH per ASTM F899 machined delivery system components for WATCHMAN FLX catheter delivery systems and coronary intervention guide components. Swiss-turned and 5-axis milled to ±0.0005" on critical interfaces, passivated per ASTM A967, and delivered with DMR/DHR-ready documentation compatible with Boston Scientific program files.

17-4 PH ASTM F899, delivery systems

CNC Services for Structural Heart and Cardiovascular Engineers

Six services, all delivered to Boston Scientific program offices, Medical Alley Tier-1 contract manufacturers, and device OEMs across Maple Grove, Plymouth, Brooklyn Park, and the Minneapolis northwest suburbs.

CNC Milling in Maple Grove

3, 4, and 5-axis milling in 316L SS, Co-Cr L-605, 17-4 PH, PEEK, and nitinol fixture tooling steel. Stent laser-cutting dies, WATCHMAN mandrel sets, inspection gauge bodies, and delivery system components on rigid centers with in-process probing.

maple-grove-mn-cnc-milling →

CNC Turning in Maple Grove

Swiss turning for nitinol mandrel ODs at ±0.0005", 17-4 PH delivery system shafts, catheter body components, and stent expansion mandrels. Co-Cr L-605 turned on rigid lathes with specialized carbide tooling and passivation per ASTM A967.

maple-grove-mn-cnc-turning →

Rapid Prototyping in Maple Grove

3-day rush prototypes in production cardiovascular tooling materials. First-article WATCHMAN mandrel geometries, stent die prototypes, and catheter hub first articles. Same-day quoting, no minimum order, NDA on request.

maple-grove-mn-rapid-prototyping →

Production Runs for Maple Grove

1 to 5,000+ part production runs with Kanban replenishment for Boston Scientific structural heart supply-chain teams. DMR/DHR-ready lots, BSCI supplier qualification-compatible documentation packages, and heat-lot traceability on every shipment.

maple-grove-mn-production-runs →

DFM Design Support in Maple Grove

Free design-for-manufacturability review on every upload. GD&T interpretation tuned to cardiovascular device tooling tolerance stacks, nitinol material constraints, stent die geometry, and Boston Scientific delivery system fit requirements.

maple-grove-mn-dfm-design-support →

Quality Assurance for Maple Grove

Zeiss CMM inspection on every order, NIST-traceable calibration, EN 10204 3.1 mill test reports, ASTM A967 passivation certs, ISO 14971 risk-flowed documentation, and BSCI supplier qualification audit-ready paper packages for Boston Scientific programs.

maple-grove-mn-quality-assurance →
Upload CAD for Instant Quote

Nine Industry Verticals, One Structural Heart Corridor Shop

Maple Grove's economy rotates around structural heart and coronary intervention device manufacturing — but the ripple hits nine different verticals, from drug-delivery fixturing to hardware startups incubating the next cardiovascular monitoring platform. RivCut serves each with the same ISO 13485-aligned process controls.

Medical Devices — Structural Heart & Stent Tooling

Boston Scientific Maple Grove is the operational center of WATCHMAN FLX LAA closure manufacturing and coronary stent tooling. Expansion mandrels, stent dies, crimping fixtures — all machined to ISO 13485, ASTM F2063/F138/F90/F899/F2026, and Boston Scientific Supplier Quality Manual.

maple-grove-mn-medical →

Aerospace — Twin Cities Tier-2

Twin Cities aerospace Tier-2 suppliers building flight hardware for commercial and defense platforms. 7075-T7351 and Ti-6Al-4V components with AS9100-aligned documentation, alongside our medical quality system.

maple-grove-mn-aerospace →

Defense — Mil-Spec Hardware

Upper Midwest defense-adjacent electronics enclosures, sensor housings, and mil-spec brackets for Minnesota defense primes. U.S.-person handling for controlled work and full traceability paperwork.

maple-grove-mn-defense →

Automotive & EV

Upper Midwest automotive R&D, aftermarket performance, and EV structural prototyping. Billet AL 7075 and 17-4 PH in short-run volumes for Minneapolis-area vehicle and e-mobility programs.

maple-grove-mn-automotive →

Robotics & Automation

Surgical-robotics end-effectors, Medical Alley automation fixtures, and production-line robotic tooling for contract manufacturers across Hennepin County. Machined in the same cleanroom-ready workflow as cardiovascular device tooling.

maple-grove-mn-robotics →

Industrial Equipment

Heavy-duty pump housings, frames, and drive components for Twin Cities industrial, food-processing, and ag-equipment teams. Large-envelope 5-axis milling and durable 4140/4340 turning.

maple-grove-mn-industrial-equipment →

Semiconductor

Wafer-handling hardware, process-chamber components, and vacuum-ready aluminum parts for Upper Midwest semiconductor and microelectronics teams. Ultra-low-particulate surface finishes on request.

maple-grove-mn-semiconductor →

Consumer Electronics

Enclosures, heatsinks, and precision housings for Twin Cities consumer electronics and health-wearable OEMs. Anodize, bead-blast, and cleanroom-compatible finishes for skin-contact wearables and cardiovascular monitoring devices.

maple-grove-mn-consumer-electronics →

Hardware Startups

Minneapolis health-tech and hardware founders building investor-demo units and first-articles. No minimums, 3-day rush, NDA on request, and free DFM on every CAD upload — often the next wave of Medical Alley structural heart device spinouts.

maple-grove-mn-hardware-startups →

Maple Grove's Named OEMs and Cardiovascular Device Corridor Neighbors

Maple Grove is the structural heart manufacturing anchor of Minnesota's Medical Alley. The OEMs are named. The device programs are specific. The flow-downs are cardiovascular-grade. RivCut speaks that language.

Boston Scientific — Structural Heart & Coronary

Boston Scientific's Maple Grove operations anchor the WATCHMAN FLX left atrial appendage closure program (FDA approved 2020, 100K+ patients) and coronary stent tooling for the PROMUS Premier, Synergy, and REBEL platforms. WATCHMAN FLX combines a nitinol frame with PTFE fabric for permanent LAA closure in nonvalvular AFib patients. Engineers here sign off on supplier qualification audits and BSCI Supplier Quality Manual flow-downs for tooling suppliers.

WATCHMAN FLXPROMUS PremierSynergy stentREBEL stent

Cardiovascular Systems Inc. (CSI)

CSI develops orbital atherectomy systems for the treatment of calcified coronary and peripheral artery disease. The Diamondback 360 and Stealth 360 systems require precision machined components and tooling. RivCut supplies machined fixturing, inspection gauges, and production tooling to support CSI's orbital atherectomy device manufacturing supply chain.

Orbital atherectomyDiamondback 360Peripheral artery

SurModics

SurModics develops surface modification and drug-delivery coating technologies for cardiovascular devices. The company's hydrophilic and drug-eluting coating platforms serve the stent and catheter device supply chain in the Maple Grove corridor. RivCut supplies precision substrate tooling and coating-process fixture hardware with ISO 13485-aligned documentation.

Surface modificationDrug-eluting coatingsCatheter coatings

Upsher-Smith Laboratories

6701 Evenstad Dr, on the Plymouth/Maple Grove border. Pharmaceutical manufacturing with adjacent needs for precision tooling, change-parts, and validated-clean fixturing in 316L stainless. GMP-adjacent workflows, full material traceability, and cleanable surface finishes for drug-contact applications in a cardiovascular pharma supply chain context.

PharmaGMP-adjacentValidated-clean tooling

Maple Grove + Plymouth: The Twin Cities Cardiovascular Corridor

Maple Grove (Boston Scientific structural heart + stent) and Plymouth (Medtronic CRM pacemakers + ICDs) sit six miles apart, forming the world's densest cardiovascular implant engineering corridor. Tooling suppliers serving Boston Scientific in Maple Grove frequently also support Medtronic Plymouth programs. RivCut operates across both cities with a single ISO 13485-aligned quality system and the same Zeiss CMM inspection workflow.

WATCHMAN FLXMedtronic CRMCardiovascular corridor

Medical Alley Association — 800+ Members

The Medical Alley Association, with more than 800 member health-and-life-sciences companies concentrated in the Twin Cities corridor, represents the dense device ecosystem that Maple Grove tooling suppliers serve. RivCut is a qualified second-source for teams inside that network when primary Medical Alley contract manufacturers are capacity-locked on Boston Scientific or Medtronic program ramps.

800+ membersMedical AlleySecond-source tooling

Built for Boston Scientific Program Schedules

Maple Grove is a three-day dock-to-door run for most of our loads — and two time zones east of our machinists in Union City, California. You sign a revised tooling drawing at 4 PM Central. We load billet at 6 AM Pacific the next morning. Your Maple Grove receiving dock sees it two business days after that, double-bagged in cleanroom packaging with Zeiss CMM and mill certs in hand.

ISO 13485 & FDA 21 CFR 820 QMS

Our quality system is structured around ISO 13485:2016, FDA 21 CFR 820 Quality System Regulation, ISO 14971 risk management, and ISO 25539 cardiovascular implant standards — and flows the Boston Scientific-specific language Maple Grove engineers expect: Boston Scientific Supplier Quality Manual compliance, BSCI supplier qualification documentation, and cardiovascular-grade ASTM material traceability.

Cardiovascular-Grade Materials, In Stock

316L SS (ASTM F138), Co-Cr L-605 (ASTM F90), 17-4 PH (ASTM F899), Ti-6Al-4V (ASTM F1472), and implant-grade PEEK (ASTM F2026) on the shelf. Nitinol tooling steel for heat-setting fixture bodies. EN 10204 3.1 mill test reports, ASTM A967 passivation certs, and heat-lot traceability on every shipment for Boston Scientific program documentation.

Union City → 55369 Logistics

3-day standard LTL via the I-94/I-90 corridor to MSP into Maple Grove. SFO/OAK → MSP daily on Delta and UPS 2A for urgent structural heart tooling orders. Parts ship double-bagged in ISO Class 7 (Class 10,000) cleanroom packaging with validated passivation and full lot traceability certs.

Cardiovascular Tooling Tolerance Capability

Nitinol mandrel OD ±0.0005", stent die geometry ±0.0003", catheter hub bores ±0.001" — tolerances driven by nitinol shape-memory sensitivity, coronary stent strut geometry requirements, and delivery system mechanical fit. We hold these on Swiss and 5-axis centers with Zeiss CMM paperwork on every order.

Upload CAD for Instant Quote

From CAD File to Maple Grove Receiving Dock

Three steps. Instant quote. Boston Scientific-flavored documentation. Ship-to-Maple-Grove in 3 business days — faster by air when a structural heart tooling order is on the line.

Step 1

Upload STEP, IGES, or SolidWorks Model

Send your STEP, IGES, or SolidWorks file. Select material from the cardiovascular device tooling list (316L ASTM F138, Co-Cr L-605 ASTM F90, 17-4 PH ASTM F899, PEEK ASTM F2026, Ti-6Al-4V ASTM F1472). We run instant pricing plus a free DFM pass. For Boston Scientific program tooling, request ISO 13485-aligned handling and BSCI supplier documentation up front.

Step 2

Machine, Inspect (Zeiss CMM), Passivate per ASTM A967

Parts run on Swiss lathes and 5-axis mills with in-process probing. ASTM A967 passivation where applicable. Zeiss CMM inspection on every order with NIST-traceable gauging. EN 10204 3.1 mill certs, DMR/DHR-ready packets, and Boston Scientific Supplier Quality Manual-compatible documentation packages when requested.

Step 3

Ship to 55369 in Cleanroom Packaging

Standard LTL to Maple Grove via the I-94/I-90 corridor in 3 business days. SFO/OAK → MSP daily on Delta and UPS 2A for urgent structural heart tooling shipments. Every part double-bagged in ISO Class 7 (Class 10,000) cleanroom packaging with full lot traceability and passivation certificates.

Built For Maple Grove

Built for the Structural Heart Cardiovascular Device Corridor

Maple Grove (45.0869°N, 93.4557°W; pop. ~74K; Hennepin County suburb ~15 miles northwest of Minneapolis) is the structural heart manufacturing capital of Minnesota's Medical Alley. Boston Scientific chose Maple Grove for its structural heart and coronary intervention manufacturing operations — anchoring the WATCHMAN FLX left atrial appendage closure program and coronary stent tooling for the PROMUS Premier, Synergy, and REBEL platforms. WATCHMAN FLX received FDA approval in 2020 for LAA closure in nonvalvular atrial fibrillation patients; the 100K+ patient milestone reflects the manufacturing scale Boston Scientific has built inside this ZIP code. Pairing with Plymouth's Medtronic CRM corridor six miles to the southeast, Maple Grove and Plymouth together form the world's densest cardiovascular implant engineering corridor — a density the Medical Alley Association's 800+ member network makes visible.

The engineering demand here is tooling and fixturing, not implants. Boston Scientific engineers need nitinol frame expansion mandrels, heat-setting fixture sets, stent laser-cutting dies, Co-Cr crimping mandrels, inspection gauges, and precision delivery system hardware. Cardiovascular Systems Inc. (CSI) requires orbital atherectomy tooling and fixturing. SurModics needs coating-process substrate fixtures. Upsher-Smith Laboratories at 6701 Evenstad Dr needs validated-clean pharma tooling. RivCut is a qualified second-source for all of it — instant online quoting, free DFM, ISO 13485-aligned documentation, Zeiss CMM inspection on every part, ASTM A967 passivation, cleanroom packaging, and no minimum order quantity. All parts are CNC machined in-house at our Bay Area facility. We never broker. We never outsource. Learn about RivCut →

Common Questions from Maple Grove, MN Engineers

Yes. RivCut machines CNC tooling and fixturing destined for Boston Scientific's structural heart and coronary intervention programs in Maple Grove — including WATCHMAN FLX frame expansion mandrels, nitinol heat-setting fixtures, stent laser-cutting fixture dies, crimping mandrels, and inspection gauges. We align our quality system with ISO 13485:2016, FDA 21 CFR 820 QSR, and ISO 14971 risk management, and we structure our supplier package to meet Boston Scientific Supplier Quality Manual requirements and BSCI supplier qualification audits.
Yes. WATCHMAN FLX frame expansion mandrels require nitinol heat-setting fixtures and expansion tooling held to ±0.0005" OD — driven by the nitinol shape-memory transformation temperature sensitivity unique to LAA closure device manufacturing. We machine nitinol fixture tooling and the mating steel mandrel sets in 316L (ASTM F138) and 17-4 PH (ASTM F899) on rigid 5-axis centers with in-process probing, and deliver Zeiss CMM reports with EN 10204 3.1 mill test reports traceable to heat and lot. ASTM F2063 UNS N01555 material traceability is flowed into our documentation package.
Yes. Coronary stent laser-cutting fixture dies in 316L stainless per ASTM F138 are a signature Maple Grove part type, driven by Boston Scientific's PROMUS Premier, Synergy, and REBEL stent programs. Die geometry tolerances of ±0.0003" are required to hold stent strut geometry during laser cutting. We machine 316L stent dies on 5-axis milling centers with diamond-point finishing passes, deliver Zeiss CMM reports, and passivate per ASTM A967 for corrosion resistance in the laser-cutting environment.
For Maple Grove cardiovascular device tooling: nitinol mandrel OD ±0.0005", stent laser-cutting die geometry ±0.0003", catheter hub bores ±0.001". These tolerances are driven by the shape-memory sensitivity of nitinol alloys, coronary stent strut geometry requirements, and the mechanical fit of delivery system components. We hold these on Swiss lathes and rigid 5-axis milling centers with Zeiss CMM verification on every order, NIST-traceable gauging, and full dimensional reports in the shipment package.
Yes. Our quality system is structured around ISO 13485:2016, FDA 21 CFR 820 Quality System Regulation, ISO 14971 risk management, and ISO 25539 cardiovascular implant standards. We flow Boston Scientific Supplier Quality Manual requirements and BSCI supplier qualification documentation — including mill test reports per EN 10204 3.1, Zeiss CMM dimensional reports, ASTM A967 passivation certificates, and DMR/DHR-ready paperwork. ASTM F2063 (nitinol), ASTM F3057 (Co-Cr), ASTM F138 (316L), ASTM F90 (Co-Cr L-605), and ASTM F2026 (PEEK) are all in our material library.
Maple Grove (55369) is a 3-day standard LTL from our Union City, CA shop via the I-94/I-90 corridor into MSP. For urgent structural heart tooling orders, SFO/OAK → MSP daily air cargo on Delta and UPS 2A gives next-day or 2-day service. Parts ship double-bagged in ISO Class 7 (Class 10,000) cleanroom packaging with validated passivation per ASTM A967 and complete mill test reports traceable to heat and lot.
Yes. Cobalt-chromium L-605 per ASTM F90 is the workhorse alloy for coronary stent mandrels, crimping fixtures, and expansion tooling in the Boston Scientific Maple Grove stent program supply chain. Co-Cr L-605 is extremely work-hardening and abrasive — we run it on rigid 5-axis centers with coated carbide and ceramic tooling, dedicated cutting parameters tuned for Co-Cr alloy, and deliver Zeiss CMM dimensional reports with ASTM F3057 and EN 10204 3.1 mill test reports.
Local Maple Grove and Medical Alley shops are excellent — but most are Boston Scientific-saturated, on long new-supplier onboarding queues, or capacity-locked on active WATCHMAN FLX and stent program ramps. RivCut gives Maple Grove engineers instant online quoting, free DFM on every upload, Zeiss CMM inspection on every part, ISO 13485-aligned documentation, cleanroom packaging, and no minimum order quantity. We're a qualified second-source for when your primary Medical Alley supplier is booked through the next structural heart product-launch cycle. 800+ Medical Alley member network; we speak the Boston Scientific supplier language.
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RivCut also serves the wider Twin Cities medical device and manufacturing corridor. Click through for city-specific landing pages with local OEMs, device programs, and logistics.

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Ship CNC Tooling to Maple Grove in Cleanroom Packaging

Instant online quote. ISO 13485 & FDA 21 CFR 820-aligned documentation. Zeiss CMM on every part. ASTM A967 passivation. 3-day LTL or next-day air to 55369. WATCHMAN FLX mandrels, stent laser-cutting dies, Co-Cr crimping tooling, and Boston Scientific program support available on request.

No minimums · Boston Scientific Supplier Quality Manual-compatible documentation · NDA & SQA on request · 3-day LTL to 55369

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