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510(k) K971105

MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM by Avecor Cardiovascular, Inc. — Product Code DTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 1997
Date Received
March 26, 1997
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)
  • 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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  • K161733 — INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C (March 8, 2017)
  • K153143 — Capiox Advance Hardshell Reservoir (December 2, 2015)
  • K151110 — Intersept Filtered Cardiotomy Reservoir (May 27, 2015)
  • K141432 — NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDI (July 7, 2014)
  • K141233 — AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSU (June 12, 2014)