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510(k) K802230

BELLCO SINGLE NEEDLE DOUBLE HEAD PUMP by Cardio Med Supplies, Inc. — Product Code FIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1980
Date Received
September 16, 1980
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 Cardio Med Supplies, Inc.

  • K080174 — PHLEBOTOMY BAG WITH VALVE & 17G X 1, MODEL CM-PH17X1B, CM-PH17X1C (April 23, 2008)
  • K042672 — 14F DUAL FLOATING DIALYSIS CATHETER/TRAY (March 23, 2005)
  • K021080 — NONCOR INFUSION SETS; NONCOR PORT INFUSION SETS (August 29, 2002)
  • K833112 — TUBING FOR CARDIOPULMONARY BYPASS (November 28, 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)
  • 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)