Affinity Pixie™ Oxygenator With Balance™ Biosurface (Model BBP211), Affinity Pixie™ Oxygenator And Cardiotomy/Venous Reservoir With Balance™ Biosurface (Model BBP241), Affinity Pixie™ Oxygenator With Cortiva™ BioActive Surface (Model CBP211), Affinit

Oxygenator, Cardiopulmonary Bypass

Medtronic Inc

The following data is part of a premarket notification filed by Medtronic Inc with the FDA for Affinity Pixie™ Oxygenator With Balance™ Biosurface (model Bbp211), Affinity Pixie™ Oxygenator And Cardiotomy/venous Reservoir With Balance™ Biosurface (model Bbp241), Affinity Pixie™ Oxygenator With Cortiva™ Bioactive Surface (model Cbp211), Affinit.

Pre-market Notification Details

Device IDK183511
510k NumberK183511
Device Name:Affinity Pixie™ Oxygenator With Balance™ Biosurface (Model BBP211), Affinity Pixie™ Oxygenator And Cardiotomy/Venous Reservoir With Balance™ Biosurface (Model BBP241), Affinity Pixie™ Oxygenator With Cortiva™ BioActive Surface (Model CBP211), Affinit
ClassificationOxygenator, Cardiopulmonary Bypass
Applicant Medtronic Inc 7611 Northland Dr Minneapolis,  MN  55428
ContactTyler Senjem
CorrespondentTyler Senjem
Medtronic Inc 7611 Northland Dr Minneapolis,  MN  55428
Product CodeDTZ  
CFR Regulation Number870.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-18
Decision Date2019-03-18

Trademark Results [Affinity Pixie]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AFFINITY PIXIE
AFFINITY PIXIE
77688089 4261650 Live/Registered
Medtronic, Inc.
2009-03-11
AFFINITY PIXIE
AFFINITY PIXIE
77545635 4105861 Live/Registered
Medtronic, Inc.
2008-08-13

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