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510(k) K031700

MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711 by Medtronic Perfusion Systems — Product Code DTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2003
Date Received
June 2, 2003
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

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  • K061254 — EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222 (June 23, 2006)
  • K052524 — BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT (November 22, 2005)
  • K052372 — MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C (September 22, 2005)
  • K051303 — BIO-CONSOLE, MODEL 560 (June 10, 2005)

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  • 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)
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