Recognized standard
F2081-06 (Reapproved 2017)
FDA recognition 3-66 · ASTM · Cardiovascular
Key facts
| Recognition number | 3-66 |
|---|---|
| Designation | F2081-06 (Reapproved 2017) |
| Title | Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents |
| Standards developer | ASTM International |
| Specialty area | Cardiovascular |
| Date of entry | Jan 14, 2019 |
| Device classes | Class 3 |
| Scope (excerpt) | This guide covers the identification of and recommended measurement methods for those dimensional attributes of vascular stents that are deemed relevant to successful clinical performance. The delivery system packaged with and labeled specifically for use during the placement of the stent is also… |
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: