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510(k) K935717

AFFINITY VENOUS RESERVIOR BAG by Avecor Cardiovascular, Inc. — Product Code DTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 1994
Date Received
November 30, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reservoir, Blood, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4400
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)
  • K940126 — AVECOR PRE-BYPASS FILTER (June 28, 1994)
  • K936003 — AFFINITY CVR (June 20, 1994)
  • K932252 — AFFINITY HOLLOW FIBER OXYGENATOR (November 19, 1993)
  • K924529 — SIGNATURE(TM) CUSTOM TUBING PACK (June 23, 1993)

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