Recognized standard
F2942-13
FDA recognition 3-138 · ASTM · Cardiovascular
Key facts
| Recognition number | 3-138 |
|---|---|
| Designation | F2942-13 |
| Title | Standard Guide for the In Vitro Axial, Bending, and Rotational Durability Test of Vascular Stents |
| Standards developer | ASTM International |
| Specialty area | Cardiovascular |
| Date of entry | Jan 14, 2019 |
| Device classes | Class 3 |
| Scope (excerpt) | This guide includes three separate cyclic deformation durability guides related to vascular stents: bending, axial, and torsional.This guide does not address flat plate, local crush durability, or multi-mode testing. |
At a glance
- 1–9 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: