Recognized standard
F2743-11
FDA recognition 3-153 · ASTM · Cardiovascular
Key facts
| Recognition number | 3-153 |
|---|---|
| Designation | F2743-11 |
| Title | Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems |
| Standards developer | ASTM International |
| Specialty area | Cardiovascular |
| Date of entry | Sep 17, 2018 |
| Scope (excerpt) | This guide describes recommended in vitro test proceduresfor coating inspection and acute particulate characterizationof coated drug-eluting vascular (balloon-expandable andself-expanding) stent systems. |
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: