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510(k) K855067

SWANK CARDIOTOMY SUCTION LINE BLOOD FILTER CA100 by Cobe Laboratories, Inc. — Product Code JOD

K855067 is an FDA 510(k) premarket notification submitted by Cobe Laboratories, Inc. for the device "SWANK CARDIOTOMY SUCTION LINE BLOOD FILTER CA100". The FDA issued a decision of Substantially Equivalent on February 26, 1986. The device falls under product code JOD (Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4270. Cobe Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1986
Date Received
December 18, 1985
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)
  • K902631 — COBE ICU CONVERSION KIT (December 17, 1990)
  • K902437 — COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER (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)
  • 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)
  • K781383 — INTERFACE CARDIOTOMY BLOOD FILTER (September 27, 1978)

FDA data resources