Recognized standard
F3067-14 (Reapproved 2021)
FDA recognition 3-178 · ASTM · Cardiovascular
Key facts
| Recognition number | 3-178 |
|---|---|
| Designation | F3067-14 (Reapproved 2021) |
| Title | Standard Guide for Radial Loading of Balloon-Expandable and Self-Expanding Vascular Stents |
| Standards developer | ASTM International |
| Specialty area | Cardiovascular |
| Date of entry | Dec 20, 2021 |
| Device classes | Class 3 |
| Scope (excerpt) | 1.1 This document provides guidance for developing in vitro test methods for measuring the radial strength or collapse pressure of balloon-expandable vascular stents and chronic outward force of self-expanding vascular stents.... |
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: