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510(k) K973760

AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE by Avecor Cardiovascular, Inc. — Product Code DTZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 1998
Date Received
October 2, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oxygenator, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4350
Review Panel
CV
Submission Type

Other clearances by Avecor Cardiovascular, Inc.

  • 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)
  • K940126 — AVECOR PRE-BYPASS FILTER (June 28, 1994)
  • 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)

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