Recognized standard
F2606-08 (Reapproved 2021)
FDA recognition 3-177 · ASTM · Cardiovascular
Key facts
| Recognition number | 3-177 |
|---|---|
| Designation | F2606-08 (Reapproved 2021) |
| Title | Standard Guide for Three-Point Bending of Balloon-Expandable Vascular Stents and Stent Systems |
| Standards developer | ASTM International |
| Specialty area | Cardiovascular |
| Date of entry | Dec 20, 2021 |
| Device classes | Class 3 |
| Scope (excerpt) | 1.1 This guide provides guidelines for quantitatively characterizing balloon-expandable stent and stent system flexibility using three-point bending procedures. Guidelines are provided for characterizing deployed stent flexibility, and for characterizing pre-deployment stent system flexibility in… |
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: