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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name oxygenator, cardiopulmonary bypass
510(k) Number K183511
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), Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Cortiva™ BioActive Surface (Model CBP241)
Applicant
Medtronic Inc
7611 Northland Dr
Minneapolis,  MN  55428
Applicant Contact Tyler Senjem
Correspondent
Medtronic Inc
7611 Northland Dr
Minneapolis,  MN  55428
Correspondent Contact Tyler Senjem
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received12/18/2018
Decision Date 03/18/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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