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B. Braun Guidewires

by B. Braun Medical Inc.

510(k) K961107

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK961107 Date1 Oct 1996ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DQX
FDA applicant
B.Braun Medical, Inc.
Device Class
Class II
Regulation
21 CFR Part 870.1330
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

B. Braun Guidewires are cardiovascular guidewires used in medical procedures. They are substantially equivalent to predicate devices and were cleared via the traditional 510(k) pathway.

The device is supplied by B. Braun Medical Inc. and is authorized under FDA 510(k) clearance K961107. It is intended for use in cardiovascular applications as indicated by the advisory committee review.

Other devices from B. Braun Medical Inc.

See all devices from B. Braun Medical Inc. →

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the B. Braun Guidewire used for?

    The B. Braun Guidewire is a cardiovascular guidewire intended for use in medical procedures involving the cardiovascular system, as indicated by its advisory committee review classification under CV (cardiovascular).

  • How is the B. Braun Guidewire supplied and authorized?

    The device is supplied by B. Braun Medical Inc. and authorized under FDA 510(k) clearance K961107, which was granted via the traditional 510(k) pathway after demonstrating substantial equivalence to a predicate device.

  • What regulatory pathway was used for the B. Braun Guidewire?

    The B. Braun Guidewire received clearance through the traditional FDA 510(k) pathway, as indicated by the clearance_type field, and was found substantially equivalent to a predicate device with decision code SESE.