Affinity Fusion Oxygenator With Balance Biosurface, Affinity Fusion Oxygenator With Cardiotomy/Venous Reservoir And Balance Biosurface, Affinity Fusion Oxygenator With Cortiva Biosurface, Affinity Fusion Oxygenator With Cortiva BioActive Surface & Ca

Oxygenator, Cardiopulmonary Bypass

Medtronic, Inc.

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

Pre-market Notification Details

Device IDK172626
510k NumberK172626
Device Name:Affinity Fusion Oxygenator With Balance Biosurface, Affinity Fusion Oxygenator With Cardiotomy/Venous Reservoir And Balance Biosurface, Affinity Fusion Oxygenator With Cortiva Biosurface, Affinity Fusion Oxygenator With Cortiva BioActive Surface & Ca
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 Received2017-09-01
Decision Date2017-10-25
Summary:summary

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