Titanium Cardiovascular Stent is a precision-manufactured selfexpanding cardiovascular stent component designed for Self-expanding cardiovascular stent (Nitinol). Fabricated from Nitinol, this component meets the stringent requirements of sterile surgical environments including corrosion resistance to bodily fluids, compatibility with repeated autoclave cycles, and non-magnetic properties for MRI compatibility.

Medical Device / Cardiovascular / SKU: TI-MD-CAR-TITANI

Titanium Cardiovascular Stent

Material Nitinol
MOQ 1 Unit
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Titanium Cardiovascular Stent — Nitinol Product Rendering
Also known as: StentVascular stentArtery stent
Technical Parameter Specification
Component SKU TI-MD-CAR-TITANI
Standards & Specifications ISO 2768-mMIL-STD-810H
Surface Finish Electropolishing Ra <0.4um + passivation
Cardiovascular SKU: TI-MD-CAR-TITANI

Titanium Cardiovascular Stent

EN 10204 3.1REACHRoHS 3ISO 2768-m
Material Grade: Nitinol (ASTM F2063)

Self-expanding cardiovascular stent (Nitinol)

Technical Specifications Matrix
Technical Parameter Specification Value
International Compliance ISO 2768-m, MIL-STD-810H
Surface Finish & Max Temp Electropolishing Ra <0.4um + passivation
📜 Quality & Traceability Gate
  • 100% Traceability: Mill Test Certificate (EN 10204 3.1) with heat analysis & mechanical testing.
  • Compliance: REACH, RoHS 3 certified. FAI AS9102 available.
⚙️ CNC & Stress Relief Controls
  • Process: CNC milling, secondary deburring, bead blast finish, final CMM inspection.
  • Thermal Stress Relief: Post-machining vacuum annealing (540-675°C under Argon) reduces distortion risk >70%.
  • Rolled Threads: Thread rolling (not cutting) increases fatigue limits by 30-50%.
Engineering FAQ
Q: What biocompatibility standards does Titanium Cardiovascular Stent comply with?

Titanium Cardiovascular Stent is manufactured from Nitinol which meets ISO 10993 biocompatibility requirements including cytotoxicity, sensitization, and irritation testing. The material's long clinical history in surgical and implantable devices provides documented biocompatibility data. All processing chemicals are selected to avoid leachables that could affect selfexpanding cardiovascular stent performance.

Q: What is the typical lead time for Titanium Cardiovascular Stent orders?

Standard lead time for Titanium Cardiovascular Stent is 15-25 business days depending on quantity and complexity. Rush orders (3-5 working days) are available for prototype evaluation. Sample evaluation (1-5 units) can be expedited to 5-7 business days. Volume pricing is available for production quantities above 100 units.

Q: What material certifications are provided with Titanium Cardiovascular Stent?

Each Titanium Cardiovascular Stent shipment includes EN 10204 Type 3.1 mill test certificate with chemical analysis, mechanical properties, and heat identification. Dimensional inspection reports and Certificate of Conformance (CoC) are standard. First Article Inspection Reports (FAIR) per AS9102 are available on request for selfexpanding cardiovascular stent.

Integration: Device Enclosure Subassembly / Internal Frame Structure
Downstream: Assembly Hardware Pack / Alignment Dowel Set / Locking Mechanism
Engineering Report & Product Documentation

§ Why Nitinol for selfexpanding cardiovascular stent

Function

Engineered as a Cardiovascular component, this part serves the specific function of . Nitinol (ASTM F2063) was selected for its proven performance in Medical Device service conditions.

Specifications

  • SKU: TI-MD-CAR-TITANI
  • Category: Cardiovascular
  • Industry: Medical Device
  • Material: Nitinol (ASTM F2063)
  • Process: CNC milling, secondary deburring, bead blast finish, final CMM inspection
  • Weight: Up to 55% weight savings compared to stainless steel alternatives

§ Biocompatibility & Dimensional Inspection

Quality Management

Manufactured under ISO 9001:2015 with full EN 10204 Type 3.1 material traceability from ingot to finished Titanium Cardiovascular Stent. All critical features are CMM-verified and documented in the First Article Inspection Report.

Inspection & NDT

100% CMM dimensional inspection per ISO 10360 on critical features; surface roughness verification per ISO 4287; material grade verification via PMI

§ Surgical-Grade Manufacturing Process

Titanium Cardiovascular Stent is manufactured using cnc milling, secondary deburring, bead blast finish, final cmm inspection. Each operation is performed by certified machinists with real-time process monitoring and dimensional verification at critical stages. Heat code traceability is maintained throughout all production steps.

Commercial Logistics & Procurement Framework

Minimum Order (MOQ) 1 Unit
Sample Evaluation 3-5 Business Days
Mass Production Lead 15-25 Business Days (Batch Dependent)
Shipping Basis EXW / FOB Shenzhen

Pricing and lead times for Titanium Cardiovascular Stent are batch-dependent. Contact our supply chain team for volume-based tiered pricing.

Regulatory & Quality Assurance Ledger

Verifiable certifications for Titanium Cardiovascular Stent

Material Test Certificate (MTC)

EN 10204 3.1

Verified

Environmental Compliance

REACH (EC No 1907/2006)

Verified

Restricted Substances

RoHS 3 Directive (2015/863/EU)

Verified

Quality Management System

AS9100D

Verified

Dimensional Tolerances

ISO 2768-m

Verified

Standard: MIL-STD-810H

MIL-STD-810H

Available upon Request

Systems Interconnectivity & Topology

Cross-functional integration matrix for Tier-1 supply chains and assembly orchestration.

Upstream System Integration
  • Device Enclosure Subassembly
  • Internal Frame Structure
Primary Inspected Component

Titanium Cardiovascular Stent

Material: Nitinol (ASTM F2063)

SKU: TI-MD-CAR-TITANI

Industry: Medical Device / System: Cardiovascular Stent & TAVI Frames

Downstream Consumables
  • Assembly Hardware Pack
  • Alignment Dowel Set
  • Locking Mechanism

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About Boze Titanium Manufacturing Center

One Metal. One Focus. Infinite Precision.

Founded in 2011 in Baoji's Titanium Valley, BOZE Metal is dedicated exclusively to titanium — from raw material to precision engineering. AS9100D, ISO 13485 & ISO 9001 certified with 500+ clients across Aerospace, Medical & Motorsport industries, we deliver end-to-end precision titanium CNC machining with full material traceability from source to component.

Boze CNC Ti is the dedicated titanium manufacturing center of Baoji Boze Metal Products Co., Ltd.

AS9100D ISO 13485 ISO 9001 500+ Clients 15+ Years OEM/ODM