FDA-recognized standard · Cardiovascular
ISO 18193: Cardiovascular implants and artificial organs - Cannulae for extracorporeal circulation
Yes. FDA recognizes ISO 18193 First edition 2021-08 as recognition 3-176, entered 2021-12-20.
Recognized editions of ISO 18193
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 3-176 | ISO 18193 First edition 2021-08 | 2021-12-20 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 18193: 21 CFR 870.1250, 21 CFR 870.4100, 21 CFR 870.4210, 21 CFR 880.5200, 21 CFR 880.5970.
Product codes that cite ISO 18193
13 FDA product codes cite ISO 18193, including DQY, DWF, FOS, FOZ, LIT.
- DQY Catheter, Percutaneous
- DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- FOS
- FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- LIT Catheter, Angioplasty, Peripheral, Transluminal
- LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- NGT Saline, Vascular Access Flush
- NZW
- NZX
- OWL
- PEF
- PEZ
- PZS
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.