Affinity NT Oxygenator With Cortiva BioActive Surface

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 With Cortiva Bioactive Surface.

Pre-market Notification Details

Device IDK162016
510k NumberK162016
Device Name:Affinity NT Oxygenator With Cortiva BioActive Surface
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 Received2016-07-21
Decision Date2016-09-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169767843 K162016 000

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