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510(k) K760384

STOPPERS by B. Braun Instruments — Product Code KGZ

K760384 is an FDA 510(k) premarket notification submitted by B. Braun Instruments for the device "STOPPERS". The FDA issued a decision of Substantially Equivalent on November 2, 1976. The device falls under product code KGZ (Accessories, Catheter), a Class I device regulated under 21 CFR 878.4200. B. Braun Instruments has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 1976
Date Received
August 5, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by B. Braun Instruments

  • K760390 — CATHETER, VEIN (BRAUNULA T) (November 2, 1976)
  • K760388 — CATHETER, VEIN (VENOFIX) (November 2, 1976)
  • K760389 — CANNULA, IV (November 2, 1976)
  • K760381 — BLOOD TRANSFUSION SET (SANGOFIX) (November 2, 1976)
  • K760382 — CONNECTORS (November 2, 1976)
  • K760385 — EXTENSION SETS (November 2, 1976)
  • K760386 — CENTRAL VEINOUS PRESSURE SETS (November 2, 1976)
  • K760387 — CATHETER, CAVA (CAVAFIX) (November 2, 1976)
  • K760391 — CATHETER, VEIN (BRAUNULA) (November 2, 1976)
  • K760383 — STOPCOCKS (November 2, 1976)

Other clearances for product code KGZ

  • K022306 — AART SILICONE TUBING (October 10, 2002)
  • K974295 — BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING (February 10, 1998)
  • K973183 — WOUND DRAINAGE HOLDER (January 23, 1998)
  • K955433 — DURALASTIC SILICONE TUBING (January 26, 1996)
  • K942315 — NAVARRE PERCUTANEOUS ACCESS SET (July 8, 1994)
  • K896087 — PALESTRANT IRRIGATION AND DRAINAGE SET (November 3, 1989)
  • K895041 — OPTICAL CATHETER(TM) INTRODUCER SETS (October 16, 1989)
  • K893406 — DESERET PRN ADAPTER (June 22, 1989)
  • K873009 — CONCEPT SWITCHING STICK (August 17, 1987)
  • K870014 — HCI GENERAL PURPOSE CATHETER STYLET (February 6, 1987)

FDA data resources