Recognized standard
F3036-21
FDA recognition 3-182 · ASTM · Cardiovascular
Key facts
| Recognition number | 3-182 |
|---|---|
| Designation | F3036-21 |
| Title | Standard Guide for Testing Absorbable Stents |
| Standards developer | ASTM International |
| Specialty area | Cardiovascular |
| Date of entry | May 30, 2022 |
| Device classes | Class 3 |
| Scope (excerpt) | 1.1 This guide covers select physical and mechanical characterizations of vascular stents with one or more absorbable components. Such absorbable stents (also referred to as vascular scaffolds) are used to provide temporary luminal support of the coronary and peripheral vasculature following… |
At a glance
- None 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: