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B.braun 612133

by B Braun Interventional Systems, Inc

B.braun 612133 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 04046955237401), active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

510(k) K021990

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04046955237401 UDI-DI Date26 Apr 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK021990 Date18 Jul 2002IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K021990 decided 18 Jul 2002 Active
  • FDA GUDID UDI-DI 04046955237401 listed 26 Apr 2019 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2917-2026 FDA Class II initiated 26 Jun 2026

    Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.

Timeline

3 dated events

  1. Cleared FDA 510(k) K021990
  2. Listed FDA GUDID 04046955237401
  3. Recall initiated FDA recalls Z-2917-2026

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
B.braun
Generic name
Cardiac/peripheral vascular guidewire, single-use
Model / Ref / Catalog
612133
Primary DI / UDI-DI
04046955237401
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

Related devices

Category: Cardiac/peripheral vascular guidewire, single-use

Cleared under the same submission (K021990)

and 8 more cleared under K021990

Similar devices in this category

Other devices filed under Cardiac/peripheral vascular guidewire, single-use.

Other devices from B Braun Interventional Systems, Inc

See all devices from B Braun Interventional Systems, Inc →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)