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Contrast Media Set

by B. Braun Medical, Inc.

510(k) K955179

Contrast Media Set is a Class II device made by B. Braun Medical, Inc., cleared under FDA 510(k) K955179 on 12 Mar 1997, active as of 8 Nov 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 8 Nov 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK955179 Date12 Mar 1997ClearedStatusActive

Official records

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  • Withdrawn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
IZI
FDA applicant
B.Braun Medical, Inc.
Device class
Class II
Regulation
21 CFR Part 892.1600
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code IZI (System, X-Ray, Angiographic).

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