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510(k) K924529

SIGNATURE(TM) CUSTOM TUBING PACK by Avecor Cardiovascular, Inc. — Product Code DWF

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
June 23, 1993
Date Received
September 8, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4210
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)
  • K935717 — AFFINITY VENOUS RESERVIOR BAG (May 10, 1994)
  • K932252 — AFFINITY HOLLOW FIBER OXYGENATOR (November 19, 1993)

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