Recognized standard
F2477-24
FDA recognition 3-200 · ASTM · Cardiovascular
Key facts
| Recognition number | 3-200 |
|---|---|
| Designation | F2477-24 |
| 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 26, 2025 |
| 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
- None Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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: