Recognized standard
F3505-21
FDA recognition 3-180 · ASTM · Cardiovascular
Key facts
| Recognition number | 3-180 |
|---|---|
| Designation | F3505-21 |
| Title | Standard Test Method for Stent and Endovascular Prosthesis Kink Resistance |
| Standards developer | ASTM International |
| Specialty area | Cardiovascular |
| Date of entry | Dec 20, 2021 |
| Device classes | Class 3 |
| Scope (excerpt) | 1.1 This standard addresses the kink resistance of stents and endovascular prostheses (for example, stent grafts). The standard may also be applicable to scaffolds. 1.2 Test methods presented herein address the kink resistance of stents and endovascular protheses when exposed to bending in a single… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
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About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: