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510(k) K780653

EXTRACORPEAL CARDIOTOMY BLOOD FILTER by Cobe Laboratories, Inc. — Product Code JOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1978
Date Received
April 19, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4270
Review Panel
CV
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 JOD

  • K993060 — GAS FILTER (March 28, 2000)
  • K890504 — CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUS (March 10, 1989)
  • K875095 — PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANE (February 29, 1988)
  • K874405 — PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE (December 30, 1987)
  • K855067 — SWANK CARDIOTOMY SUCTION LINE BLOOD FILTER CA100 (February 26, 1986)
  • K841958 — CARDIO METRICS CARDIOTOMY RESERVOIR (October 15, 1984)
  • K830634 — CARDIOTOMY FILTER (June 30, 1983)
  • K823259 — INTERFACE CARDIOTOMY BLOOD FILTER #50 (November 24, 1982)
  • K823260 — INTERFACE CARDIOTOMY BLOOD FILTER #51 (November 24, 1982)
  • K812243 — INTERFACE CARDIOTOMY BLOOD FILTER #51 (August 25, 1981)