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510(k) K993060

GAS FILTER by Olson Medical Sales, Inc. — Product Code JOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2000
Date Received
September 13, 1999
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 Olson Medical Sales, Inc.

  • K000977 — COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER COILS (March 23, 2001)
  • K993062 — CHEST DRAINAGE TUBING (December 10, 1999)
  • K992906 — COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT (November 10, 1999)

Other clearances for product code JOD

  • 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)
  • K781383 — INTERFACE CARDIOTOMY BLOOD FILTER (September 27, 1978)