Home / 510(k) Clearances / K820173

510(k) K820173

COBE SINGLE-NEEDLE CONTROLLER #18-756 by Cobe Laboratories, Inc. — Product Code FIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1982
Date Received
January 21, 1982
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 Cobe Laboratories, Inc.

  • K923272 — COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR (May 11, 1993)
  • K900105 — COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC (March 22, 1991)
  • K905793 — COBE CENTRY 2 BICART OPTION KIT (February 12, 1991)
  • K905388 — COBE CENTRYSYSTEM 3 BICART OPTION KIT (February 11, 1991)
  • K904336 — NEW COBE SATURATION/HEMATOCRIT MONITOR (December 27, 1990)
  • K902437 — COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER (December 17, 1990)
  • K902631 — COBE ICU CONVERSION KIT (December 17, 1990)
  • K904566 — NEW COBE CENTRYSYSTEM(TM) 100 HG DIALYZER (December 12, 1990)
  • K902758 — COBE SATURATION/HEMATOCRIT MONITOR W/ FIBER OPTIC (August 23, 1990)
  • K902759 — COBE CLOSED WOUND DRAINAGE KIT (July 18, 1990)

Other clearances for product code FIF

  • K873279 — 8810 PUMP-PUMP SINGLE NEEDLE DEVICE (October 23, 1987)
  • K802230 — BELLCO SINGLE NEEDLE DOUBLE HEAD PUMP (December 22, 1980)
  • K801967 — MEDCOMP FEMORAL VEIN CATHETER (September 26, 1980)
  • K792174 — MODEL DM 353 & DM-353-L SINGLE NEEDLE (November 16, 1979)
  • K772147 — GW 35 GUIDE WIRE (November 28, 1977)