Medical-device CNC machining for Union City, CA. RivCut supplies medical-device CNC machining to engineering and manufacturing teams across Union City and Northern California and nearby Maple Grove. Parts are machined 100% in the USA at our Union City, California facility and ship to Union City nationwide — with expedited air and AOG options when a production line is down.
Union City, California to Maple Grove, Minnesota is a 1,950-mile three-day FedEx Freight ground lane, with SFO and OAK direct to MSP on Delta Cargo and UPS 2A for urgent clinical-build support. Every Union City order ships with CMM inspection, full material traceability, and a first-article report on request.
approval year
implanted worldwide
OD tolerance (17 sizes)
aligned, audit-ready
Precision CNC Machining for Maple Grove Medical Device Teams
Boston Scientific suppliers feeding the Maple Grove cardiovascular campus need parts that are dimensionally exact, fully traceable, and aligned to Boston Scientific SQMS. A WATCHMAN FLX expansion mandrel that is 0.001 inch off OD will mismatch the nitinol frame heat-setting and scrap the lot. RivCut machines 17-4 PH H900 to ASTM F899, 316L to ASTM F138, Co-Cr L-605 to ASTM F90, and medical-grade PEEK to ASTM F2026 with sub-0.001 inch tolerances on cardiovascular tooling, issues Zeiss CMM reports with every first-article build, and ships double-bagged in ISO Class 7 cleanroom packaging so Boston Scientific Maple Grove incoming inspection does not re-package.
ISO 13485-Aligned Documentation
Our quality system follows ISO 13485:2016 structure, integrates with FDA 21 CFR 820 QSR and ISO 14971 risk management, and supports 21 CFR Part 11 e-records for Boston Scientific SQMS program audit.
Cardiovascular-Grade Materials
17-4 PH H900 (ASTM F899), 316L (ASTM F138), Co-Cr L-605 (ASTM F90), Ti-6Al-4V (ASTM F136), and medical-grade PEEK (ASTM F2026) — all with lot-genealogy traceability to the mill heat and ingot.
Passivation & Cleanroom Packaging
ASTM A967 nitric or citric passivation, ISO 10993 biocompatibility routing, and ISO Class 7 double-bag cleanroom packaging so parts are Maple Grove receiving-ready out of the box.
What We Machine for Maple Grove Medical Device Teams
The Boston Scientific Maple Grove supply chain runs on cardiovascular intervention tooling — WATCHMAN FLX mandrels, coronary stent fixture dies, and catheter delivery components. We machine all of them to SQMS documentation discipline.
WATCHMAN FLX Expansion Mandrels
Heat-setting and expansion mandrels for the WATCHMAN FLX nitinol frame in all 17 production sizes (20mm through 35mm OD). Mandrel OD held at ±0.0005 inch to ensure consistent nitinol shape-setting. Machined in 17-4 PH H900 with Ra ≤ 0.4 µm on the nitinol contact zone. Zeiss CMM report and 3.1 mill cert with every lot.
17-4 PH H900, ±0.0005", 17 sizesStent Laser-Cutting Fixture Dies
Coronary stent laser-cutting fixture dies in 316L stainless to ASTM F138. Bore ID held at ±0.0003 inch for consistent wall thickness on PROMUS Premier, Synergy, and REBEL cobalt-chromium stents during laser tube cutting. Ra ≤ 0.2 µm on bore ID for Synergy abluminal polymer coating compatibility. ASTM A967 passivation standard.
316L ASTM F138, ±0.0003" boreCoronary Stent Expansion Mandrels
Balloon-expandable stent post-expansion mandrels in 17-4 PH H900 to ASTM F899 for PROMUS Premier and REBEL stent crimping and expansion process validation. Swiss-type turning with live tooling holds ±0.0003 inch on mandrel OD steps used to verify final stent diameter across the expansion range.
17-4 PH H900 ASTM F899, ±0.0003"Catheter Delivery System Components
Luer fittings, hub bodies, and push-rod components for WATCHMAN FLX and coronary stent catheter delivery systems in medical-grade PEEK per ASTM F2026 and 17-4 PH H900. Lumen concentricity ±0.001 inch, luer fitting interference tolerances held for saline-bath reliability testing. USP Class VI polymer material certification.
PEEK ASTM F2026, 17-4 PH, ±0.001"Co-Cr L-605 Structural Heart Tooling
Structural heart device tooling in Co-Cr L-605 alloy to ASTM F90 — the same cobalt-chromium alloy used in coronary stent platforms. Fixture blocks, crimping dies, and forming tooling for transcatheter heart valve and structural heart programs. Machined on dedicated Co-Cr spindles, Ra ≤ 0.4 µm on forming surfaces, ASTM A967 passivation.
Co-Cr L-605 ASTM F90, Ra ≤ 0.4 µmCardiovascular Device Inspection Gauges
Go/no-go gauges, plug gauges, and CMM reference fixtures for cardiovascular device dimensional verification in the Boston Scientific Maple Grove quality labs. Machined tighter than the device under inspection — typically ±0.0002 inch on reference features in 17-4 PH H900, with Zeiss CMM certification of gauge accuracy included in every lot package.
±0.0002" reference features, gauge certsParts for Maple Grove Medical Device Companies
WATCHMAN FLX mandrels, stent fixture dies, coronary stent expansion tooling, catheter delivery components, structural heart tooling, and inspection gauges — every part cut for the Boston Scientific Maple Grove supply chain.
WATCHMAN FLX Nitinol Frame Mandrels (20–35mm, 17 sizes)
Heat-setting mandrels for all 17 WATCHMAN FLX production sizes. 17-4 PH H900, ±0.0005 inch OD, Ra ≤ 0.4 µm on nitinol contact surfaces. Zeiss CMM report and ASTM A967 passivation cert with every lot.
17-4 PH H900, ASTM F899, ±0.0005"PROMUS Premier & Synergy Stent Fixture Dies
Laser-cutting fixture dies in 316L ASTM F138 for PROMUS Premier, Synergy, and REBEL stents. Bore ID ±0.0003 inch, Ra ≤ 0.2 µm for Synergy polymer coating compatibility. ASTM A967 passivation standard.
316L ASTM F138, ±0.0003" bore IDCoronary Stent Crimping & Expansion Tooling
Post-expansion and crimping mandrels in 17-4 PH H900 for PROMUS and REBEL stent process validation. ±0.0003 inch on stepped OD diameters. Swiss-type turning with CMM verification on every build.
17-4 PH H900, ±0.0003" OD stepsWATCHMAN Catheter Luer & Hub Bodies
Luer fittings and hub bodies for WATCHMAN FLX delivery catheter systems in medical-grade PEEK (ASTM F2026) and 17-4 PH H900. Lumen concentricity ±0.001 inch. USP Class VI polymer documentation.
PEEK ASTM F2026, 17-4 PH H900Structural Heart Co-Cr L-605 Tooling
Fixture blocks and crimping dies in Co-Cr L-605 (ASTM F90) for transcatheter heart valve programs. Ra ≤ 0.4 µm on forming surfaces, ASTM A967 passivation. Dedicated Co-Cr spindles prevent cross-contamination.
Co-Cr L-605 ASTM F90Cardiovascular Device Inspection Gauges
Go/no-go plug gauges and CMM reference fixtures in 17-4 PH H900. ±0.0002 inch on reference features. Zeiss CMM gauge-certification report and ASTM A967 passivation cert. Tighter than the device under inspection.
17-4 PH H900, ±0.0002" gauge featuresMaple Grove's Cardiovascular Device Ecosystem
The I-94 northwest corridor through Maple Grove hosts one of the most concentrated cardiovascular device manufacturing clusters in North America — anchored by Boston Scientific and supported by a dense supply chain of ISO 13485 contract manufacturers, coating specialists, and engineering services firms.
Boston Scientific WATCHMAN FLX — the world's leading LAA closure device
The WATCHMAN FLX left atrial appendage closure device received FDA PMA approval in 2020 and has been implanted in over 100,000 patients worldwide. The nitinol frame's 17 production sizes (20mm through 35mm OD) require precision expansion mandrels that must hold ±0.0005 inch OD to ensure consistent heat-setting and shape-setting across every production lot. RivCut machines all 17 mandrel sizes to that specification with Zeiss CMM certification on every first-article build.
Coronary stent tooling — ±0.0003" drives every stent lot
The PROMUS Premier, Synergy, and REBEL stent families are manufactured on cobalt-chromium tube stock laser-cut in precision fixture dies. The die bore ID must be held at ±0.0003 inch to maintain consistent stent wall thickness within specification across the full laser-cutting run. A fixture die that is 0.001 inch out of bore will produce a scrapped stent lot. RivCut machines these dies in 316L ASTM F138 with Ra ≤ 0.2 µm on the bore ID for Synergy polymer coating compatibility.
SurModics & Cardiovascular Systems — adjacent ecosystem demand
SurModics (Eden Prairie, bordering Maple Grove) develops hydrophilic and drug-delivery surface coatings applied to cardiovascular device substrates. Cardiovascular Systems Inc. (CSI) develops atherectomy systems requiring precision rotating contact components. Both programs feed demand for 316L and Ti-6Al-4V substrate components machined to tight Ra and dimensional tolerances that RivCut supplies into the Medical Alley northwest corridor.
Upsher-Smith Labs & Medical Alley northwest corridor density
Upsher-Smith Labs (6701 Evenstad Drive, Maple Grove / Plymouth border) anchors pharmaceutical manufacturing in the immediate area. The Medical Alley Association's broader northwest suburban network — Maple Grove, Plymouth, and Minnetonka — concentrates ISO 13485 supplier capacity that supports both Boston Scientific Maple Grove and Medtronic Plymouth programs simultaneously. RivCut slots into that supply chain as the Bay Area precision machining partner with three-day LTL ground transit to 55369.
Boston Scientific — Maple Grove Cardiovascular Operations
Maple Grove, MN 55369. Boston Scientific's Maple Grove campus is the engineering and manufacturing center for the WATCHMAN FLX left atrial appendage closure system and the PROMUS Premier, Synergy, and REBEL coronary stent platforms. The Supplier Quality Management System (SQMS) governs all supplier qualification and documentation. The Boston Scientific Supplier Portal runs the purchase-order and PPAP-equivalent qualification workflow for Maple Grove program suppliers.
Cardiovascular Systems Inc. (CSI)
CSI develops and manufactures orbital atherectomy systems for treating calcified cardiovascular disease. Precision rotating contact components for atherectomy crowns require 316L and Ti-6Al-4V machined to sub-0.001 inch tolerances with ASTM A967 passivation — a profile directly in our Maple Grove medical machining capability. CSI is part of the Maple Grove / Plymouth medical device corridor that feeds Medical Alley supplier demand.
SurModics — Surface Modification Chemistry
SurModics (Eden Prairie) develops hydrophilic, drug-delivery, and biocompatibility coatings applied to cardiovascular device substrates — including stent platforms and catheter surfaces — that are machined by suppliers in the Maple Grove corridor. RivCut machines 316L and Ti-6Al-4V substrate components for SurModics coating validation programs, held to the surface-finish specifications their coating chemistry protocols require, with ASTM A967 passivation and cleanroom packaging to prevent substrate contamination.
Upsher-Smith Labs & Medical Alley Association
Upsher-Smith Labs at 6701 Evenstad Drive sits on the Maple Grove / Plymouth border — pharmaceutical manufacturing with a lean CNC footprint but significant local ecosystem weight. The Medical Alley Association anchors the broader northwest suburban network with 800-plus member companies. The I-94 industrial corridor in Maple Grove — home to Boston Scientific, CSI, and adjacent to SurModics and Upsher-Smith — is the densest cardiovascular device cluster in Hennepin County outside of the Medtronic Plymouth campus.
Why Maple Grove Medical Device Teams Work with RivCut
Union City, California to Maple Grove, Minnesota is a 1,950-mile three-day FedEx Freight ground lane, with SFO and OAK direct to MSP on Delta Cargo and UPS 2A for urgent clinical-build support. Your supplier-quality engineer can open a deviation on a Monday and we can have revised parts on the Maple Grove Boston Scientific dock Tuesday morning.
Boston Scientific SQMS Documentation Discipline
We build lot-release packages that satisfy Boston Scientific SQMS incoming inspection on the first pass — 3.1 mill certs, heat and lot genealogy, ASTM A967 passivation certificates, and Zeiss CMM dimensional reports tied to your STEP PMI. For new part numbers we run the SQMS-compatible qualification package through the Boston Scientific Supplier Portal so your Maple Grove supplier-engineering contact does not have to chase documentation.
Cardiovascular Tooling Precision
WATCHMAN FLX expansion mandrels at ±0.0005 inch OD and stent laser-cutting fixture dies at ±0.0003 inch bore ID — that is the Maple Grove tolerance story we are built for. Ra ≤ 0.4 µm on nitinol contact zones and Ra ≤ 0.2 µm on Synergy stent die bores are verified on a stylus profilometer, and our Zeiss CMM programs read PMI directly from your native SolidWorks or STEP AP242 models so dimensional reports ballot back to the design.
Cardiovascular Materials in Stock
17-4 PH H900 to ASTM F899, 316L to ASTM F138, Co-Cr L-605 to ASTM F90, Ti-6Al-4V to ASTM F136, and medical-grade PEEK to ASTM F2026. Every lot ships with 3.1 mill certs, ingot-level heat traceability, and — for polymers — resin lot numbers, so Boston Scientific Maple Grove incoming inspection does not re-test.
Cleanroom-Ready to Maple Grove
FedEx Freight and Old Dominion LTL deliver 55369 on a three-business-day ground transit from our Union City shop. Urgent clinical-build and first-article parts fly SFO or OAK to MSP on Delta Cargo or UPS 2A, landing in Maple Grove by 10:30 AM. All implant-grade tooling ships double-bagged in ISO Class 7 cleanroom packaging, validated-passivated per ASTM A967, so the Maple Grove receiving dock does not re-package.
(20mm–35mm OD, ±0.0005")
3-day ground, 1-day air to 55369
on STEP / SolidWorks uploads
ISO 13485 aligned, SQMS-ready
Need our full quality evidence package or an ISO 13485 supplier questionnaire before ordering? Email us — we'll send everything your Maple Grove supplier-quality team needs to qualify.
How to Get Maple Grove Medical Device Parts Quoted and Cut
Boston Scientific program timelines move with design-history-file closure dates and SQMS audit cycles. Here is how RivCut keeps up with Maple Grove.
Upload CAD + Device Program Info
Send your STEP, SolidWorks, or Creo model with the Boston Scientific program name (WATCHMAN FLX, PROMUS Premier, Synergy, REBEL, etc.) and the Boston Scientific Supplier Portal part number. Flag any SQMS flow-down, ISO 10993 biocompatibility note, or nitinol heat-setting process spec so we scope material and tooling-surface requirements early.
We Cut, Passivate & Zeiss CMM Verify
17-4 PH H900 mandrels and 316L fixture dies run on thermally stable 5-axis mills; Co-Cr L-605 tooling on dedicated Co-Cr spindles; PEEK catheter components on polymer-dedicated spindles. ASTM A967 passivation on all metallic parts, Ra ≤ 0.4 µm profilometer checks on forming and contact surfaces, and Zeiss CMM dimensional verification on every first-article before lot release.
Ship Double-Bagged to Maple Grove (55369)
Parts ship in ISO Class 7 cleanroom double-bag packaging to 55369 or direct to Boston Scientific Maple Grove receiving. Every lot carries 3.1 mill certs, heat and lot genealogy, ASTM A967 passivation certificate, Zeiss CMM dimensional report, and — for Boston Scientific programs — the full SQMS-compatible qualification package.
Find Your Exact Part Type
We machine parts for every corner of the Maple Grove cardiovascular device market.
WATCHMAN FLX Mandrels
17 sizes 20–35mm OD, ±0.0005", 17-4 PH H900
Stent Laser-Cutting Fixture Dies
316L ASTM F138, ±0.0003" bore ID
Stent Expansion Mandrels
17-4 PH H900 ASTM F899, ±0.0003" OD
Catheter Delivery Components
PEEK ASTM F2026 & 17-4 PH, luer fittings, hub bodies
Co-Cr L-605 Structural Heart Tooling
ASTM F90, Ra ≤ 0.4 µm forming surfaces
Cardiovascular Inspection Gauges
±0.0002" reference features, gauge certs
Questions from Maple Grove Medical Device Teams
Medical Device CNC Machining in Other Twin Cities
We serve medical device teams across the Medical Alley footprint.
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CNC Services in Maple Grove, MN
Built for Boston Scientific's Cardiovascular Supply Chain
Maple Grove is not a generic medical-device city. It is the cardiovascular intervention city. The Boston Scientific Maple Grove campus anchors the I-94 northwest corridor in Hennepin County and ships WATCHMAN FLX left atrial appendage closure devices, PROMUS Premier, Synergy, and REBEL coronary stents, and the catheter delivery systems that route all of them to cardiologists and electrophysiologists worldwide. The WATCHMAN FLX FDA PMA approval in 2020 and subsequent 100,000-plus patient implantation milestone created a sustained demand for precision nitinol expansion mandrels in all 17 production sizes — tooling that must hold ±0.0005 inch OD across a production run to ensure consistent heat-setting of the nitinol frame. Coronary stent laser-cutting fixture dies in 316L ASTM F138 must hold ±0.0003 inch on the bore ID — 0.001 inch off and the stent wall thickness drifts outside specification across the cut run. Cardiovascular Systems Inc. develops atherectomy systems in the same northwest corridor. SurModics develops hydrophilic and drug-delivery coatings applied to cardiovascular device substrates machined by the same supplier base. Upsher-Smith Labs anchors pharmaceutical manufacturing on the Maple Grove / Plymouth border. The Medical Alley Association's northwest suburban network ties all of them into the 800-plus-member Medical Alley ecosystem. RivCut machines into that supply chain from Union City, California: 17-4 PH H900 WATCHMAN FLX mandrels to ASTM F899, 316L stent fixture dies to ASTM F138, Co-Cr L-605 structural heart tooling to ASTM F90, PEEK catheter delivery components to ASTM F2026, and inspection gauges to ±0.0002 inch reference accuracy — all double-bagged in ISO Class 7 cleanroom packaging with ASTM A967 passivation certificates and Zeiss CMM dimensional reports aligned to Boston Scientific SQMS incoming-inspection expectations. Three-day LTL to 55369, or same-day SFO/OAK-to-MSP Delta Cargo for urgent clinical-build support.
Start Your Maple Grove Medical Device Quote Today
RivCut is ready to feed the Boston Scientific Maple Grove supply chain — WATCHMAN FLX expansion mandrels, stent laser-cutting fixture dies, coronary stent expansion tooling, PEEK catheter delivery components, and Co-Cr L-605 structural heart tooling. Upload your STEP or SolidWorks file and get a same-day quote. Parts ship double-bagged to 55369.
Get a Maple Grove Medical Device Quote →
Currently accepting new projects
AI price estimates are usually within ±20% of final price. Complex parts — especially Co-Cr L-605 structural heart tooling and WATCHMAN FLX mandrel sets — may get a human review within one business day before pricing is confirmed.
Why Maple Grove, MN Medical Device Companies Choose RivCut
Maple Grove, MN (Hennepin County, ~82K city population, NW Twin Cities at 45.0869°N, -93.4557°W, ZIP 55369) is the operational heart of Boston Scientific's cardiovascular device business and a Medical Alley anchor. The local supply chain spans Boston Scientific WATCHMAN FLX and coronary stent programs, Cardiovascular Systems Inc., SurModics, and Upsher-Smith Labs. RivCut machines parts into that supply chain from our Union City, CA facility with three-day LTL to 55369 and same-day SFO/OAK-MSP Delta Cargo for clinical-build and urgent first-article support.
All parts are CNC machined in-house at our Bay Area shop. We never broker or outsource machining. Learn about RivCut →