CNC machining with full quality assurance for Maple Grove, MN. RivCut supplies CNC machining with full quality assurance to engineering and manufacturing teams across Maple Grove and the Upper Midwest. Parts are machined 100% in the USA at our Union City, California facility and reach Maple Grove in about 4–5 business days by ground freight — with expedited air and AOG options when a production line is down.
Cardiovascular Systems, Inc. (CSI) produces orbital and rotational atherectomy catheters near Maple Grove. Every Maple Grove order ships with CMM inspection, full material traceability, and a first-article report on request.
nitinol mandrel OD
mandrel OD mapped
316L & 17-4 PH tooling
21 CFR Part 11 compliant
What Does Cardiovascular Tooling QA Actually Mean?
Most shops say "we do CMM inspection." A Maple Grove cardiovascular tooling supplier says something very different: ISO 13485:2016 quality management with lot traceability back to the Device History Record, FDA 21 CFR 820 QSR receiving-inspection conformance, 21 CFR Part 11 electronic records with audit trails on every measurement, ASTM F2063 nitinol material certification traced to heat and lot, ASTM A967 passivation travelers with ferroxyl test results for all stainless tooling, Zeiss CMM with nitinol mandrel OD mapped at all 36 angular positions for WATCHMAN expansion uniformity assurance, and stent die bore geometry, lumen concentricity, and clearance-angle verification per ISO 25539 tooling requirements. Boston Scientific cardiovascular programs demand that whole stack, not just the measurement step.
Plan the Quality
Ballooned drawing, ISO 13485 clause mapping, PFMEA, control plan, and DHR linkage before the first chip flies. For nitinol mandrels: 36-position OD measurement protocol defined up front.
Inspect with Evidence
Zeiss CMM with feature-by-feature actuals, GD&T to ASME Y14.5-2018, Cpk studies on mandrel OD taper zones, stent die bore/concentricity/clearance-angle actuals, and 21 CFR Part 11 audit-trail PDF/A output.
Ship the Package
First article with 36-position OD polar map, CMM report, 3.1 ASTM F2063 mill cert, passivation traveler, PEEK USP Class VI data sheet where applicable, and a CofC tied to ISO 13485 clause 7.5. Nothing chased after the fact.
Maple Grove Cardiovascular Tooling & Their QA Footprint
From WATCHMAN expansion mandrels to stent laser-cutting die sets, each Boston Scientific tooling type has a different CMM protocol and documentation trail. Here is what we cover and how.
Maple Grove (pop. ~70K) hosts Boston Scientific's WATCHMAN FLX left-atrial appendage closure and PROMUS/Synergy coronary stent manufacturing operations. Both programs depend on precision cardiovascular tooling — nitinol expansion mandrels and heat-setting fixtures for the WATCHMAN nitinol frame, and stainless laser-cutting die sets, crimping mandrels, and inspection gauges for the coronary stent program. That tooling drives a documentation-heavy QA stack: ISO 13485:2016 plus FDA 21 CFR 820 QSR plus ASTM F2063 nitinol traceability plus ASTM A967 passivation plus 21 CFR Part 11 electronic records plus Cpk ≥ 1.67 on mandrel OD critical features.
The surrounding Maple Grove cluster adds to the load: Cardiovascular Systems, Inc. (CSI) atherectomy catheter tooling, SurModics surface-treatment process fixtures, and Upsher-Smith Labs manufacturing support tooling. Each customer expects a QA package that speaks ISO 13485 and 21 CFR 820 fluently on day one, with ASTM F2063 and ISO 25539 standards awareness built in.
Nitinol Expansion Mandrels (WATCHMAN)
WATCHMAN FLX expansion mandrels in nitinol (ASTM F2063). Zeiss CMM OD measurement at all 36 angular positions (10° increments), Cpk ≥ 1.67 on critical taper zones, EN 10204 3.1 mill cert with Af transformation temperature confirmation. First article with polar OD deviation map on every lot.
ASTM F2063 Nitinol · 36-position OD mapStent Laser-Cutting Die Sets
316L and 17-4 PH stent die sets with Zeiss CMM verification of bore diameter (lumen clearance), bore concentricity relative to mounting datum, clearance angle geometry (0.5–2°), chamfer inlet/outlet geometry, and face parallelism. ASTM A967 Nitric 2 passivation with ferroxyl test result. ISO 13485 FAIR on every campaign.
316L / 17-4 PH · ASTM A967 · ISO 25539PEEK Catheter Hub Production Runs
PEEK (ASTM F2026) catheter hubs for WATCHMAN delivery system and coronary catheter programs. 100% CMM on fluid-path bore, seal-face OD, and connector geometry. USP Class VI biocompatibility data sheet. ISO 13485 first article and 21 CFR Part 11 PDF/A inspection records on every production lot.
PEEK F2026 · USP Class VI · 100% CMM17-4 PH Inspection Gauges
Stent OD/ID go/no-go gauges, crimper mandrel gauges, and WATCHMAN frame inspection fixtures in 17-4 PH H900. ASTM A967 Citric 3 passivation, Cpk studies on gauge OD, Ra finish verification on gauge surfaces. ISO 13485 CofC with gauge calibration traceability to NIST.
17-4 PH H900 · ASTM A967 Citric 3Nitinol Heat-Setting Fixtures
WATCHMAN frame heat-setting fixtures and nitinol component setting mandrels. CMM verification of form accuracy against the target Af profile geometry. ASTM F2063 material traceability. ISO 13485 first article. 21 CFR Part 11 compliant inspection records tied to the validated heat-treatment IQ/OQ/PQ process lot.
ASTM F2063 · IQ/OQ/PQ linkageStent Crimping Mandrel Sets
316L and 15-5 PH crimping mandrels for coronary stent assembly. CMM verification of mandrel OD profile, taper geometry, and Ra surface finish on the stent-contact zone. ASTM A967 passivation, EN 10204 3.1 mill cert, ISO 13485 FAIR with every crimping mandrel production set.
316L / 15-5 PH · ASTM A967 · Surface Ra
WATCHMAN FLX 28mm Expansion Mandrel — ASTM F2063 Nitinol
Produced as a first-article lot for a Maple Grove WATCHMAN cardiovascular tooling program. ASTM F2063 nitinol bar stock with Af temperature confirmation, 5-axis CNC turned and polished, Zeiss CMM run with 36-position OD polar map at every 10-degree interval across three axial stations. Cpk 1.79 on the critical taper zone. Shipped with full ISO 13485 documentation to Maple Grove in 7 business days.
mandrel taper zone
CMM-mapped
critical taper CTQ
first submission
- ISO 13485:2016 first-article inspection with full ballooned callouts
- 36-position OD polar map with Cpk data on critical taper zone
- EN 10204 3.1 ASTM F2063 mill cert with Af transformation temperature
- CMM report as 21 CFR Part 11 PDF/A with embedded audit trail
- CofC aligned to ISO 13485 clause 7.5 and 21 CFR 820.80 receiving inspection
Inspection. Traceability. Process Control.
The three pillars of a Maple Grove-grade cardiovascular tooling QA package. Missing any one of them leaves a gap in the WATCHMAN or stent tooling Device History Record.
Inspection Evidence
Measurements are reported, not just made.
- Zeiss CMM at ±0.0001", NIST-traceable
- 36-position OD polar map for nitinol mandrels
- 21 CFR Part 11 PDF/A with audit trail
- Cpk ≥ 1.67 on CTQ features per lot
Material Traceability
Every part traced from finished dimension back to melt.
- EN 10204 3.1 mill cert per heat / lot
- ASTM F2063 nitinol with Af temperature
- ASTM F138 316L, F899 17-4 PH, F90 Co-Cr L-605
- PEEK USP Class VI data sheet for catheter hubs
Process Control
Special processes routed through validated partners.
- ASTM A967 Nitric 2 / Citric 3 passivation
- Ferroxyl test included with every traveler
- IQ/OQ/PQ validated process lot linkage
- Boston Scientific supplier quality system alignment
From Ballooned Drawing to Shipped Package
Three steps. No missing certificates. Built for Boston Scientific cardiovascular tooling supplier-quality auditors.
Submit Drawing, Model & Tooling Specs
Upload STEP AP242 model and ballooned 2D drawing. Call out ASTM F2063 nitinol, ASTM F138/F899/F90 stainless/Co-Cr material, ISO 13485 clause references, 21 CFR Part 11 expectations, and WATCHMAN or stent program context. Flag 36-position OD measurement protocol for mandrels. We confirm Boston Scientific supplier quality system alignment before quoting.
Machine, Passivate, and Inspect
We machine in Union City, CA. Passivation runs ASTM A967 Nitric 2 or Citric 3 for all stainless tooling. Zeiss CMM runs ISO 13485 first-article balloon report with 36-position OD polar map for mandrels, or bore/concentricity/clearance-angle verification for stent dies, output as 21 CFR Part 11 PDF/A with Cpk data on every CTQ feature.
Ship Part + Full Package to Maple Grove
Part, FAIR or PPAP-equivalent, CMM report with OD polar map and Cpk data, 3.1 ASTM F2063/F138/F899 mill cert, passivation traveler, PEEK USP Class VI data sheet, and a CofC aligned to ISO 13485 clause 7.5 and 21 CFR 820 QSR arrive together. 3-day ground LTL via I-94 to Maple Grove or next-day SFO to MSP air on urgent WATCHMAN or stent production work.
Why Maple Grove, MN Cardiovascular Tooling Teams Choose RivCut
Maple Grove (pop. ~70K, Hennepin County, ZIP 55369) is home to Boston Scientific's WATCHMAN FLX and coronary stent manufacturing operations. Cardiovascular tooling demand spans nitinol expansion mandrels, stent laser-cutting die sets, crimping mandrels, heat-setting fixtures, and inspection gauges for the WATCHMAN and PROMUS/Synergy programs. The nearby Cardiovascular Systems, Inc. (CSI) and SurModics operations add interventional-cardiology catheter tooling and surface-treatment fixture QA requirements. RivCut machines, inspects, and passivates cardiovascular tooling parts at our Union City, CA facility, shipping 3-day ground LTL via I-94 to Maple Grove or next-day SFO to MSP air cargo for production-critical windows.
All parts are CNC machined in-house at our Bay Area shop. We never broker or outsource the machining. Learn about RivCut →
Common Questions About Cardiovascular Tooling QA in Maple Grove
Cardiovascular Tooling Materials Stocked for Maple Grove QA Work
Every alloy ships with a 3.1 mill cert traced to heat and lot, cross-checked against ASTM F2063, F138, F899, F90, F2026, and F1472 requirements. ASTM A967 passivation available for all stainless tooling. ASTM F2063 Af temperature confirmation available for all nitinol stock.
| Nitinol (ASTM F2063) | |
|---|---|
| Nitinol Bar / Tube | ASTM F2063, WATCHMAN expansion mandrels, heat-setting fixtures, superelastic tooling; 3.1 MTR with Af temperature |
| Implant Stainless (ASTM F138 / F899) | |
| 316L CRES | ASTM F138, stent laser-cutting dies, catheter hub bodies; ASTM A967 Nitric 2 passivation |
| 17-4 PH H900 | ASTM F899, stent die sets (high-wear applications), inspection gauges; ASTM A967 Citric 3 |
| 15-5 PH H900 | Crimping mandrels, delivery-system fixture hardware; ASTM A967 passivation |
| Cobalt-Chromium (ASTM F90) | |
| Co-Cr L-605 | ASTM F90, stent die inserts for extreme-wear applications, WATCHMAN frame tooling inserts |
| Titanium (ASTM F1472) | |
| Ti-6Al-4V | ASTM F1472, catheter delivery handle fixtures, lightweight tooling frames |
| Polymers (PEEK / Medical PC) | |
| PEEK (ASTM F2026) | ASTM F2026 / USP Class VI, WATCHMAN delivery catheter hubs, coronary catheter hub inserts |
| Medical Polycarbonate | USP Class VI, transparent fluid-path details and catheter delivery handle housings |
| Aluminum and General Tooling | |
| 6061-T6 | Process fixtures, assembly jigs, inspection fixture frames; hard anodize available |
| 4140 Pre-hard | Stent die backing plates, fixturing structures, production tooling support bodies |
Need a specific ASTM callout or Af temperature range? Ask us — we stock and trace cardiovascular tooling grades on request.
RivCut vs CNC Marketplaces vs Local Machine Shops
Why quality engineers supporting Boston Scientific cardiovascular tooling programs choose RivCut. Marketplaces quote fast but rarely carry nitinol machining capability or ASTM F2063 traceability discipline. Local Twin Cities shops are rigorous but slow on quotes. RivCut combines instant online quoting with the 36-position mandrel OD inspection and passivation documentation a Boston Scientific supplier-quality audit actually requires.
| What You Get | RivCut Best | CNC Marketplace | Local Machine Shop |
|---|---|---|---|
| ISO 13485:2016 alignment | QMS mapped on every new PN | Paid upgrade or not offered | Varies by shop |
| Nitinol mandrel 36-position OD map | Zeiss CMM, every 10°, Cpk data | Not offered | Varies by shop |
| 21 CFR Part 11 compliant records | PDF/A + audit trail + e-sig | Not supported | Ad-hoc paperwork |
| ASTM F2063 nitinol traceability | 3.1 MTR with Af temperature | Often not stocked | On request |
| ASTM A967 passivation traveler | Nitric 2 / Citric 3, ferroxyl test | Not offered | Varies by shop |
| Stent die CMM (bore/concentricity/angle) | 5-feature verification per die | Manual gauge typical | Varies by shop |
| Lead time to FAI / PPAP-equivalent | 5–7 business days (3 rush) | 2–3 weeks typical | 3–5 weeks |
| Ship to Boston Scientific Maple Grove | 3-day LTL / next-day air | 5–7 days transit | Local delivery |
What Quality Engineers Say
About Working With RivCut
Real reviews from engineers shipping to Boston Scientific Maple Grove and the broader cardiovascular tooling cluster.
RivCut shipped the WATCHMAN mandrel lot with 36-position OD mapping at every 10-degree interval, Cpk 1.79 on the critical taper zones, and a full ASTM F2063 3.1 mill cert. The first article cleared our Boston Scientific supplier quality review on first submission. That almost never happens with a West Coast shop.
WATCHMAN Tooling316L stent laser-cutting dies with Zeiss CMM on bore geometry, clearance angles, and lumen concentricity. ASTM A967 passivation traveler with ferroxyl test. Every document we needed for our DHR was already in the package when the box arrived. No chasing certs after the fact.
Stent Die SetsPEEK catheter hub production run with 100% CMM on the fluid-path bore and seal-face features. ISO 13485 first article, 21 CFR Part 11 PDF/A, EN 10204 3.1 PEEK cert. Documentation discipline you'd expect from a Medical Alley shop, not a California supplier. We're running kanban replenishment now.
PEEK Catheter HubsQuality Assurance Near Maple Grove
How Maple Grove's Cardiovascular Tooling Cluster Uses Quality Assurance
Boston Scientific anchors Maple Grove with WATCHMAN and coronary stent production. Here is how each layer of the cardiovascular tooling supply chain uses a QA package.
Built for Boston Scientific's Cardiovascular Tooling QA Stack
The Maple Grove cardiovascular tooling QA stack is as documentation-heavy as anything in Medical Alley, but the vocabulary is entirely different from implantable device QA. A single WATCHMAN FLX expansion mandrel lot ships with: ISO 13485:2016 first-article inspection (ballooned drawing with all feature callouts, 100% pass on first article of any lot), FDA 21 CFR 820 Quality System Regulation conformance with receiving-inspection alignment to 820.80, 21 CFR Part 11 compliant electronic records (audit trail, electronic signatures, tamper-evident PDF/A), Zeiss CMM report with 36-position OD polar map at every 10-degree interval across three axial stations, Cpk ≥ 1.67 on critical taper zone CTQ features, EN 10204 3.1 ASTM F2063 mill cert traced to heat and lot with Af transformation temperature confirmed per ASTM F3057 DSC, ASTM A967 passivation traveler for any stainless tooling components with ferroxyl test result, PEEK USP Class VI biocompatibility data sheet for catheter hub components, and a Certificate of Conformance cross-referencing ISO 13485 clause 7.5 plus 21 CFR 820 QSR receiving-inspection requirements. Those records feed forward into the customer's Device History Record (DHR) and backward to the Device Master Record (DMR) revision number on every shop traveler. That is what Maple Grove cardiovascular tooling QA means in practice. Generic shops say ‘we CMM inspect.’ A Maple Grove cardiovascular tooling supplier says ‘ISO 13485 FAIR with 36-position nitinol OD polar map, Cpk 1.67+ on taper CTQ, ASTM F2063 3.1 cert with Af temperature, A967 Nitric 2 passivation with ferroxyl, and 21 CFR Part 11 PDF/A.’ RivCut runs the full Maple Grove cardiovascular tooling stack from our Union City, CA shop floor: same Zeiss CMM, same 3.1 MTR discipline, same refusal to chase certs after the fact. That is what the documentation burden of cardiovascular tooling actually requires, and it is why Boston Scientific and CSI tooling teams keep coming back.
Upload Your Drawing & Model for a Maple Grove QA Quote
ISO 13485:2016. 21 CFR Part 11 electronic records. Nitinol mandrel 36-position OD inspection. ASTM F2063 traceability. ASTM A967 passivation. FAI packages in 5 to 7 business days, 3 on rush.
ISO 13485 FAIR · 21 CFR Part 11 · ASTM F2063 nitinol traceability · ASTM A967 passivation · 3-day LTL to Maple Grove