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510(k) K792174

MODEL DM 353 & DM-353-L SINGLE NEEDLE by Extracorporeal Medical Specialities, Inc. — Product Code FIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1979
Date Received
October 29, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Dialysis, Single Needle With Uni-Directional Pump
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)
  • K840532 — HEMOPERFUSION SYSTEM TP-400 (May 30, 1984)
  • K840262 — HANCOCK PERICARDIAL PATCH (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)
  • K833477 — INTERSEPT 40 MICRON FILTER (December 27, 1983)
  • K833476 — INTERSEPT 40 MICRON FILTER W/TUBING (December 27, 1983)
  • K831424 — THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101 (October 14, 1983)

Other clearances for product code FIF

  • K873279 — 8810 PUMP-PUMP SINGLE NEEDLE DEVICE (October 23, 1987)
  • K820173 — COBE SINGLE-NEEDLE CONTROLLER #18-756 (March 23, 1982)
  • K802230 — BELLCO SINGLE NEEDLE DOUBLE HEAD PUMP (December 22, 1980)
  • K801967 — MEDCOMP FEMORAL VEIN CATHETER (September 26, 1980)
  • K772147 — GW 35 GUIDE WIRE (November 28, 1977)