FDA-recognized standard · Cardiovascular
ISO 12417-1: Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements
Yes. FDA recognizes ISO 12417-1 Second edition 2024-02 as recognition 3-193, entered 2024-12-23. FDA also lists ISO 12417-1 First edition 2015-10-01 (recognition 3-143, transition period ending 2026-12-20).
Recognized editions of ISO 12417-1
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 3-193 | ISO 12417-1 Second edition 2024-02 | 2024-12-23 | Complete | — |
| 3-143 | ISO 12417-1 First edition 2015-10-01 | 2016-06-27 | Complete | 2026-12-20 |
Product codes that cite ISO 12417-1
9 FDA product codes cite ISO 12417-1, including NIQ, NIU, NVN, NVY, NXW.
- NIQ
- NIU
- NVN
- NVY
- NXW
- OJX
- ONU
- OOB
- PRC
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.