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510(k) K861226

INTERFACE CRYSTALLOID CARDIOPLEGIC FILTER MODEL 70 by Medical, Inc. — Product Code KRJ

K861226 is an FDA 510(k) premarket notification submitted by Medical, Inc. for the device "INTERFACE CRYSTALLOID CARDIOPLEGIC FILTER MODEL 70". The FDA issued a decision of Substantially Equivalent on June 2, 1986. The device falls under product code KRJ (Filter, Prebypass, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4280. Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1986
Date Received
April 1, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Prebypass, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4280
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)
  • K851370 — INTERFACE TRANSFUSION BLOOD FILTER #35 (June 27, 1985)
  • K823261 — INTERFACE TRANSFUSION BLOOD FILTER #30 (January 7, 1983)
  • K823259 — INTERFACE CARDIOTOMY BLOOD FILTER #50 (November 24, 1982)

Other clearances for product code KRJ

  • K990276 — POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER (October 1, 1999)
  • K982385 — POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER (February 1, 1999)
  • K940126 — AVECOR PRE-BYPASS FILTER (June 28, 1994)
  • K900672 — PREBYPASS FILTER, CAT. NO. FPB-5 (April 3, 1990)
  • K885154 — INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM (February 22, 1989)
  • K884390 — INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTER (December 21, 1988)
  • K884244 — INTERSEPT* PREBYPASS FILTER (December 5, 1988)
  • K883086 — INTERSEPT*PREBYPASS FILTER (September 16, 1988)
  • K875094 — ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE (February 29, 1988)
  • K871350 — PREBYPASS FILTER (June 8, 1987)

FDA data resources