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510(k) K760781

TRIEX-1 HOLLOW FIBER DIALYZER by Extracorporeal Medical Specialities, Inc. — Product Code FJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1976
Date Received
October 5, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intracatheter, Dialysis
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Extracorporeal Medical Specialities, Inc.

  • K843955 — EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR (November 29, 1984)
  • K840262 — HANCOCK PERICARDIAL PATCH (May 30, 1984)
  • K840532 — HEMOPERFUSION SYSTEM TP-400 (May 30, 1984)
  • K840057 — EXP* 500 PARALLEL PLATE DIALYZER (February 4, 1984)
  • K840146 — EXP* 700 PARALLEL PLATE DIALYZER (February 4, 1984)
  • K831423 — THERAPEUTIC EXCHANGE SYSTEM (January 3, 1984)
  • K832547 — ULTRAFILTRATION CONTROLLER (January 3, 1984)
  • K833476 — INTERSEPT 40 MICRON FILTER W/TUBING (December 27, 1983)
  • K833477 — INTERSEPT 40 MICRON FILTER (December 27, 1983)
  • K831424 — THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101 (October 14, 1983)

Other clearances for product code FJT

  • K863297 — MODIFICATION'S TO TORAY'S B-2 SERIES (September 25, 1986)
  • K772146 — CATHETER, VEIN, FEMORAL, SF 10 (November 29, 1977)
  • K772148 — CATHETER, FEMORAL VEIN, SF 6 (November 29, 1977)
  • K770047 — DNC 151 VINCA-FLO (January 14, 1977)