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510(k) K781383

INTERFACE CARDIOTOMY BLOOD FILTER by Medical, Inc. — Product Code JOD

K781383 is an FDA 510(k) premarket notification submitted by Medical, Inc. for the device "INTERFACE CARDIOTOMY BLOOD FILTER". The FDA issued a decision of Substantially Equivalent on September 27, 1978. The device falls under product code JOD (Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4270. Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1978
Date Received
August 11, 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 Medical, Inc.

  • K082311 — EXSUDEX WOUND DRAINAGE PUMP (October 8, 2008)
  • K926454 — ANESTHESIA RESPIRATORY BREATH CIRCUIT PACKS/COMPON (June 22, 1993)
  • K894839 — OS-1 OCCLUSION SYSTEM - 1 (October 24, 1989)
  • K872001 — MODEL TPC-1A OXYGEN ANALYZER (June 15, 1987)
  • K863806 — MODEL A-1 OXYGEN ANALYZER (October 15, 1986)
  • K862609 — INTERFACE ARTERIAL BLOOD FILTER, MODEL 44 (September 4, 1986)
  • K862591 — INTERFACE ARTERIAL BLOOD FILTER, MODEL 42 (September 4, 1986)
  • K861226 — INTERFACE CRYSTALLOID CARDIOPLEGIC FILTER MODEL 70 (June 2, 1986)
  • K851370 — INTERFACE TRANSFUSION BLOOD FILTER #35 (June 27, 1985)
  • K823261 — INTERFACE TRANSFUSION BLOOD FILTER #30 (January 7, 1983)

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)

FDA data resources