Affinity NT Oxygenator With Balance Biosurface, Affinity NT Oxygenator With Balance Biosurface And Uncoated Cardiotomy/Venous Reservoir

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 Balance Biosurface, Affinity Nt Oxygenator With Balance Biosurface And Uncoated Cardiotomy/venous Reservoir.

Pre-market Notification Details

Device IDK191444
510k NumberK191444
Device Name:Affinity NT Oxygenator With Balance Biosurface, Affinity NT Oxygenator With Balance Biosurface And Uncoated Cardiotomy/Venous Reservoir
ClassificationOxygenator, Cardiopulmonary Bypass
Applicant Medtronic, Inc. 7611 Northland Drive Minneapolis,  MN  55428
ContactHarsh Dharamshi
CorrespondentHarsh Dharamshi
Medtronic, Inc. 7611 Northland Drive Minneapolis,  MN  55428
Product CodeDTZ  
CFR Regulation Number870.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-31
Decision Date2019-09-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20763000187846 K191444 000

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