Recognized standard
25539-1: 2017
FDA recognition 3-157 · ANSI · Cardiovascular
Key facts
| Recognition number | 3-157 |
|---|---|
| Designation | 25539-1: 2017 |
| Title | Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses |
| Standards developer | American National Standards Institute |
| Specialty area | Cardiovascular |
| Date of entry | Jan 14, 2019 |
| Device classes | Class 3, HDE |
| Scope (excerpt) | 25539-1 specifies requirements for the evaluation of endovascular systems (prostheses and delivery systems) and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer based upon current medical knowledge. Guidance for the development of in vitro… |
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: