FDA-recognized standard · Cardiovascular
ISO 25539-2: Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
Yes. FDA recognizes ISO 25539-2 Third edition 2020-09 as recognition 3-181, entered 2022-05-30.
Recognized editions of ISO 25539-2
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 3-181 | ISO 25539-2 Third edition 2020-09 | 2022-05-30 | Complete | — |
Product codes that cite ISO 25539-2
8 FDA product codes cite ISO 25539-2, including MAF, MIH, NIM, NIN, NIO.
- MAF
- MIH
- NIM
- NIN
- NIO
- NIP
- NIQ
- PFV
Source: FDA Recognized Consensus Standards database, snapshot of 2026-09-01. Search every recognition in the Consensus Standards Lookup, or browse all standards with a page.