Affinity NT Oxygenator, Affinity NT Oxygenator With Trillium Biosurface

Oxygenator, Cardiopulmonary Bypass

MEDTRONIC, INC.

The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Affinity Nt Oxygenator, Affinity Nt Oxygenator With Trillium Biosurface.

Pre-market Notification Details

Device IDK162896
510k NumberK162896
Device Name:Affinity NT Oxygenator, Affinity NT Oxygenator With Trillium Biosurface
ClassificationOxygenator, Cardiopulmonary Bypass
Applicant MEDTRONIC, INC. 8200 CORAL SEA STREET NE (MVS83) Mounds View,  MN  55112
ContactRenee Cveykus
CorrespondentRenee Cveykus
MEDTRONIC, INC. 8200 CORAL SEA STREET NE (MVS83) Mounds View,  MN  55112
Product CodeDTZ  
CFR Regulation Number870.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2016-10-17
Decision Date2016-12-06
Summary:summary

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