Home / 510(k) Clearances / K940126

510(k) K940126

AVECOR PRE-BYPASS FILTER by Avecor Cardiovascular, Inc. — Product Code KRJ

K940126 is an FDA 510(k) premarket notification submitted by Avecor Cardiovascular, Inc. for the device "AVECOR PRE-BYPASS FILTER". The FDA issued a decision of Substantially Equivalent on June 28, 1994. The device falls under product code KRJ (Filter, Prebypass, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4280. Avecor Cardiovascular, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1994
Date Received
January 10, 1994
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 Avecor Cardiovascular, Inc.

  • K973760 — AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE (February 18, 1998)
  • K964017 — AFFINITY BLOOD PUMP SYSTEM (August 5, 1997)
  • K971105 — MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM (July 11, 1997)
  • K952532 — AFFINITY ARTERIAL BLOOD FILTER (October 6, 1995)
  • K936003 — AFFINITY CVR (June 20, 1994)
  • K935717 — AFFINITY VENOUS RESERVIOR BAG (May 10, 1994)
  • K932252 — AFFINITY HOLLOW FIBER OXYGENATOR (November 19, 1993)
  • K924529 — SIGNATURE(TM) CUSTOM TUBING PACK (June 23, 1993)

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

FDA data resources