Affinity NT Oxygenator, Affinity NT Oxygenator With Trillium Biosurface, Affinity NT Oxygenator With Carmeda 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, Affinity Nt Oxygenator With Carmeda Biosurface.

Pre-market Notification Details

Device IDK143073
510k NumberK143073
Device Name:Affinity NT Oxygenator, Affinity NT Oxygenator With Trillium Biosurface, Affinity NT Oxygenator With Carmeda Biosurface
ClassificationOxygenator, Cardiopulmonary Bypass
Applicant Medtronic, Inc. 7611 Northland Drive Minneapolis,  MN  55428
ContactJessica Sixberry
CorrespondentJessica Sixberry
Medtronic, Inc. 7611 Northland Drive Minneapolis,  MN  55428
Product CodeDTZ  
CFR Regulation Number870.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-10-27
Decision Date2015-03-25
Summary:summary

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