Affinity Pixie Oxygenator With Balance Biosurface, Affinity Pixie Oxygenator With Cardiotomy/Venous Reservoir And Balance Biosurface, Affinity Pixie Oxygenator With Cortiva BioActive Surface, Affinity Fusion Oxygenator With Cardiotomy/Venous Reservoi

Oxygenator, Cardiopulmonary Bypass

Medtronic, Inc.

The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Affinity Pixie Oxygenator With Balance Biosurface, Affinity Pixie Oxygenator With Cardiotomy/venous Reservoir And Balance Biosurface, Affinity Pixie Oxygenator With Cortiva Bioactive Surface, Affinity Fusion Oxygenator With Cardiotomy/venous Reservoi.

Pre-market Notification Details

Device IDK172984
510k NumberK172984
Device Name:Affinity Pixie Oxygenator With Balance Biosurface, Affinity Pixie Oxygenator With Cardiotomy/Venous Reservoir And Balance Biosurface, Affinity Pixie Oxygenator With Cortiva BioActive Surface, Affinity Fusion Oxygenator With Cardiotomy/Venous Reservoi
ClassificationOxygenator, Cardiopulmonary Bypass
Applicant Medtronic, Inc. 8200 Coral Sea Street NE Mounds View,  MN  55112
ContactLisa Stone
CorrespondentLisa Stone
Medtronic, Inc. 8200 Coral Sea Street NE Mounds View,  MN  55112
Product CodeDTZ  
CFR Regulation Number870.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2017-09-27
Decision Date2017-11-20
Summary:summary

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