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510(k) K961147

CLOSED FLUID COLLECTION SYSTEM by B.Braun Medical, Inc. — Product Code GBX

K961147 is an FDA 510(k) premarket notification submitted by B.Braun Medical, Inc. for the device "CLOSED FLUID COLLECTION SYSTEM". The FDA issued a decision of Substantially Equivalent on May 31, 1996. The device falls under product code GBX (Catheter, Irrigation), a Class I device regulated under 21 CFR 878.4200. B.Braun Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 1996
Date Received
March 21, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Irrigation
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by B.Braun Medical, Inc.

  • K253235 — Introcan Safety® Deep Access XL IV Catheter (May 15, 2026)
  • K243392 — Infusomat® Space Volumetric Infusion Pump Administration Sets (July 24, 2025)
  • K240578 — VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter (July 31, 2024)
  • K241845 — Introcan Safety® 2 IV Catheter (July 26, 2024)
  • K241385 — Omnifix Syringe NRFit (July 13, 2024)
  • K231242 — Perifix FX Catheter; Contiplex FX Catheter (September 15, 2023)
  • K223479 — AQUAbase nX (August 16, 2023)
  • K220756 — Introcan Safety 2 IV Catheter (June 23, 2022)
  • K220626 — Introcan Safety IV Catheter (May 14, 2022)
  • K213778 — IV Administration Set (March 3, 2022)

Other clearances for product code GBX

  • K131659 — MOERAE VEIN PREPARATION KIT (March 3, 2014)
  • K082725 — GRAFTGUARD PRESSURE CONTROLLING SYRINGE (December 17, 2008)
  • K052286 — DEUTSCH ANTI-BLOCKAGE WOUND DRAIN (October 21, 2005)
  • K043515 — GRAFTSAVER (March 31, 2005)
  • K013417 — MISONIX IRRIGATION SYSTEM MOEDL BC20P (January 10, 2002)
  • K000704 — DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS) (May 19, 2000)
  • K974233 — LYSONIX IRRIGATION SYSTEM (February 3, 1998)
  • K973703 — JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN (December 4, 1997)
  • K972635 — ULTRACELL SUCTION SPONGE (October 1, 1997)
  • K965146 — FLAT CLOSED WOUND DRAIN WITH TROCAR (March 10, 1997)

FDA data resources