FDA-recognized standard · General Plastic Surgery/General Hospital
ISO 10555-1: Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements
Yes. FDA recognizes ISO 10555-1 Third edition 2023-11 as recognition 6-499, entered 2024-05-29.
Recognized editions of ISO 10555-1
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 6-499 | ISO 10555-1 Third edition 2023-11 | 2024-05-29 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 10555-1: 21 CFR 870.1250, 21 CFR 880.5200, 21 CFR 880.5970.
Product codes that cite ISO 10555-1
11 FDA product codes cite ISO 10555-1, including DQY, FOS, FOZ, LIT, LJS.
- DQY Catheter, Percutaneous
- 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
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.