Recognized standard
F2477-23
FDA recognition 3-184 · ASTM · Cardiovascular
Key facts
| Recognition number | 3-184 |
|---|---|
| Designation | F2477-23 |
| Title | Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses |
| Standards developer | ASTM International |
| Specialty area | Cardiovascular |
| Date of entry | May 29, 2023 |
| Device classes | Class 3, HDE |
| Scope (excerpt) | 1.1 These test methods cover the determination of the durability of a vascular stent or endoprosthesis by exposing it to diametric deformation by means of hydrodynamic pulsatile loading. This testing occurs on a test sample that has been deployed into a mock (elastically simulated) vessel. The test… |
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: