Recognized standard
F3374-19
FDA recognition 3-162 · ASTM · Cardiovascular
Key facts
| Recognition number | 3-162 |
|---|---|
| Designation | F3374-19 |
| Title | Standard Guide for Active Fixation Durability of Endovascular Prostheses |
| Standards developer | ASTM International |
| Specialty area | Cardiovascular |
| Date of entry | Dec 23, 2019 |
| Device classes | Class 3 |
| Scope (excerpt) | This guide addresses how to conduct in vitro durability testing on active fixation components (AFCs) and attachment mechanisms of endovascular prostheses. It does not address the durability of fixation systems that reside solely within the vessel lumen to resist device migration (e.g, radial force… |
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: