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510(k) K760380

INTRAVENOUS TRANSFER SET (INTRAFIX) by B. Braun Instruments — Product Code JCY

K760380 is an FDA 510(k) premarket notification submitted by B. Braun Instruments for the device "INTRAVENOUS TRANSFER SET (INTRAFIX)". The FDA issued a decision of Substantially Equivalent on November 2, 1976. The device falls under product code JCY (Catheter, Infusion), 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
Catheter, Infusion
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)
  • K760384 — STOPPERS (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)

Other clearances for product code JCY

  • K863982 — VAS-CATH PERICARDIOCENTESIS CATHETER, SET & TRAY (October 24, 1986)
  • K840324 — SILICONE SUMP DRAIN 20 & 40 FRENCH (April 25, 1984)
  • K834615 — TRIPLE LUMEN INFUSIONCATHETERS- (February 14, 1984)
  • K831453 — SILCATH CENTRAL CATHETER TRAY W/18 GA (July 28, 1983)
  • K831451 — SILCATH CENTRAL CATHETER TRAY SIZE- (June 8, 1983)
  • K822096 — CHEMOTHERAPY INFUSION CATHETER (April 12, 1983)
  • K813606 — SILICONE ELASTOMER INFUSION CATHETER (January 18, 1982)
  • K791372 — JELCO & KVO CATHETER PLACEMENT UNIT (September 12, 1979)
  • K771861 — CATHETER, CEBTRAL VENOUS, 2N1501 (November 28, 1977)
  • K760760 — CATHETER, INTRAVASCULAR (ARGYLE IV SK) (December 9, 1976)

FDA data resources