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510(k) K812244

INTERFACE PRE BYPASS PRIME FILTER #90 by Medical, Inc. — Product Code KRJ

K812244 is an FDA 510(k) premarket notification submitted by Medical, Inc. for the device "INTERFACE PRE BYPASS PRIME FILTER #90". The FDA issued a decision of Substantially Equivalent on Aug 25, 1981. The device falls under product code KRJ (Filter, Prebypass, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4280. Medical, Inc. has 21 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 25, 1981
Date Received
Aug 11, 1981
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
510(k) Exempt

Other clearances by Medical, Inc.

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

Other clearances for product code KRJ

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

FDA data resources

Source: FDA 510(k) database entry for K812244. Report a data issue: hello@regdatalab.com.