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510(k) K771861

CATHETER, CEBTRAL VENOUS, 2N1501 by Travenol Laboratories, S.A. — Product Code JCY

K771861 is an FDA 510(k) premarket notification submitted by Travenol Laboratories, S.A. for the device "CATHETER, CEBTRAL VENOUS, 2N1501". The FDA issued a decision of Substantially Equivalent on November 28, 1977. The device falls under product code JCY (Catheter, Infusion), a Class I device regulated under 21 CFR 878.4200. Travenol Laboratories, S.A. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 1977
Date Received
October 3, 1977
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 Travenol Laboratories, S.A.

  • K874181 — BAXTER BEDSIDE SYSTEM (February 22, 1988)
  • K873894 — CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITE (November 5, 1987)
  • K873873 — RESUBMITTED MICRON TRANSFUSION FILTER (October 22, 1987)
  • K873984 — AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437) (October 20, 1987)
  • K872364 — HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 (October 13, 1987)
  • K872652 — UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM (September 30, 1987)
  • K870801 — FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD (September 4, 1987)
  • K871908 — IV ADMINISTRATION SET (July 27, 1987)
  • K871471 — CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15 (June 12, 1987)
  • K865029 — CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER (April 17, 1987)

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)
  • K760760 — CATHETER, INTRAVASCULAR (ARGYLE IV SK) (December 9, 1976)
  • K760380 — INTRAVENOUS TRANSFER SET (INTRAFIX) (November 2, 1976)

FDA data resources