Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System

Oxygenator, Cardiopulmonary Bypass

Medtronic

The following data is part of a premarket notification filed by Medtronic with the FDA for Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System.

Pre-market Notification Details

Device IDK203111
510k NumberK203111
Device Name:Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System
ClassificationOxygenator, Cardiopulmonary Bypass
Applicant Medtronic 7611 Northland Drive Minneapolis,  MN  55428
ContactKaitlin Cady
CorrespondentKaitlin Cady
Medtronic 7611 Northland Drive Minneapolis,  MN  55428
Product CodeDTZ  
CFR Regulation Number870.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-15
Decision Date2021-09-16

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