B.braun 612154
by B Braun Interventional Systems, Inc
B.braun 612154 is a Class II device made by B Braun Interventional Systems, Inc, cleared under FDA 510(k) K021990 on 18 Jul 2002 and listed in FDA GUDID since 26 Apr 2019 (UDI-DI 04046955308415), active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04046955308415 | Date26 Apr 2019 | StatusListed |
| United States | FDA 510(k) | NumberK021990 | Date18 Jul 2002 | StatusActive |
Official records
- AccessGUDID record 04046955308415
- FDA 510(k) database K021990
Across registries
- FDA 510(k) K021990 decided 18 Jul 2002 Active
- FDA GUDID UDI-DI 04046955308415 listed 26 Apr 2019 Listed
Recalls
-
- Ongoing Z-2917-2026
Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.
Timeline
- Cleared FDA 510(k) K021990
- Listed FDA GUDID 04046955308415
- Recall initiated FDA recalls Z-2917-2026
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- B.braun
- Generic name
- Cardiac/peripheral vascular guidewire, single-use
- Model / Ref / Catalog
- 612154
- Primary DI / UDI-DI
- 04046955308415
- FDA product code
- DQX
- GMDN term
- Cardiac/peripheral vascular guidewire, single-use
- Device class
- Class II
- Regulation number
- 870.1330
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Cardiac/peripheral vascular guidewire, single-use.