Home / 510(k) Clearances / K900672

510(k) K900672

PREBYPASS FILTER, CAT. NO. FPB-5 by American Omni Medical, Inc. — Product Code KRJ

K900672 is an FDA 510(k) premarket notification submitted by American Omni Medical, Inc. for the device "PREBYPASS FILTER, CAT. NO. FPB-5". The FDA issued a decision of Substantially Equivalent on April 3, 1990. The device falls under product code KRJ (Filter, Prebypass, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4280. American Omni Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1990
Date Received
February 13, 1990
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 American Omni Medical, Inc.

  • K922781 — FLOW CONROL VALVE (March 8, 1993)
  • K922356 — FLOW CONTROL VALVE, CAT. NO. ACV-38 (February 12, 1993)
  • K884893 — CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25 (January 30, 1989)
  • K884640 — CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700 (January 24, 1989)
  • K873316 — BUBBLE TRAP-FILTER CAT. NO B180F37 (July 14, 1988)
  • K875080 — AIR VENT LINE CAT. NO. AVL-36 (February 29, 1988)
  • K873802 — PRESSURE BARRIER KIT CAT. NO. PBK-3 (November 6, 1987)
  • K873610 — PEDIATRIC BUBBLE TRAP CAT. NO. B-100 (November 5, 1987)
  • K873488 — SILENT GUARD CAT. NO. SG-10 (October 7, 1987)
  • K871632 — NASOGASTRIC VOICETUBE (September 16, 1987)

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)
  • 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)
  • K861226 — INTERFACE CRYSTALLOID CARDIOPLEGIC FILTER MODEL 70 (June 2, 1986)

FDA data resources