Recognized standard
F2942-19
FDA recognition 3-189 · ASTM · Cardiovascular
Key facts
| Recognition number | 3-189 |
|---|---|
| Designation | F2942-19 |
| Title | Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents |
| Standards developer | ASTM International |
| Specialty area | Cardiovascular |
| Date of entry | Dec 18, 2023 |
| Device classes | Class 3 |
| Scope (excerpt) | 1.1 This guide includes three separate cyclic deformation durability guides related to vascular stents: bending, axial, and torsional. 1.2 This guide does not address flat plate, local crush durability, or multi-mode testing. Although this guide does not address multi-mode testing, the information… |
At a glance
- 10–99 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: