Affinity Fusion Oxygenator With Integrated Arterial Filter And Balance Biosurface, Affinity Fusion Oxygenator With Integrated Arterial Filter And Carmeda 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 Fusion Oxygenator With Integrated Arterial Filter And Balance Biosurface, Affinity Fusion Oxygenator With Integrated Arterial Filter And Carmeda Bioactive Surface.

Pre-market Notification Details

Device IDK142784
510k NumberK142784
Device Name:Affinity Fusion Oxygenator With Integrated Arterial Filter And Balance Biosurface, Affinity Fusion Oxygenator With Integrated Arterial Filter And Carmeda BioActive Surface
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-26
Decision Date2014-10-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169785762 K142784 000
00643169785731 K142784 000

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