AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG

Defoamer, Cardiopulmonary Bypass

MEDTRONIC PERFUSION SYSTEMS

The following data is part of a premarket notification filed by Medtronic Perfusion Systems with the FDA for Affinity Vard Sub-assembly For Cps (carmeda Coated), Purgeline (uncoated), Holding Bag.

Pre-market Notification Details

Device IDK101186
510k NumberK101186
Device Name:AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG
ClassificationDefoamer, Cardiopulmonary Bypass
Applicant MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis,  MN  55432
ContactCaralee Walton
CorrespondentCaralee Walton
MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis,  MN  55432
Product CodeDTP  
CFR Regulation Number870.4230 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2010-04-28
Decision Date2010-09-03

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