FDA-recognized standard · Cardiovascular
ISO 25539-4: Cardiovascular implants - Endovascular devices - Part 4: Application of ISO 17327-1 for coated endovascular devices
Yes. FDA recognizes ISO 25539-4 First edition 2021-11 as recognition 3-197, entered 2024-12-23.
Recognized editions of ISO 25539-4
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 3-197 | ISO 25539-4 First edition 2021-11 | 2024-12-23 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 25539-4: 21 CFR 870.3375, 21 CFR 870.3450.
Product codes that cite ISO 25539-4
13 FDA product codes cite ISO 25539-4, including DSY, DTK, DYF, MAL, MIH.
- DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
- DTK
- DYF
- MAL
- MIH
- NIP
- NIQ
- NIU
- NXW
- PFV
- PNY
- PRL
- QSK
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.