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510(k) K854517

NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SET by Travenol Laboratories, S.A. — Product Code FKK

K854517 is an FDA 510(k) premarket notification submitted by Travenol Laboratories, S.A. for the device "NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SET". The FDA issued a decision of Substantially Equivalent on December 2, 1985. The device falls under product code FKK (Clamp, Line), a Class I device regulated under 21 CFR 876.4730. Travenol Laboratories, S.A. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 1985
Date Received
November 12, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Line
Device Class
Class I
Regulation Number
876.4730
Review Panel
GU
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 FKK

  • K854512 — TUBING CLAMP CAT#1000-A (December 2, 1985)
  • K844121 — CLAMP, TUBING, LINE (December 17, 1984)
  • K831689 — EMPTY DIALYSATE CONTAINER (August 11, 1983)
  • K822551 — AMP CAPD UNISPIKE AMINISTRATION SET (October 13, 1982)
  • K802009 — FLOWCLAMP CAT.#1011 & 1012 (October 31, 1980)

FDA data resources