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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 K142784
Device Name Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface
Applicant
Medtronic, Inc
8200 Coral Sea Street NE
Mounds View,  MN  55112
Applicant Contact Lisa Stone
Correspondent
Medtronic, Inc
8200 Coral Sea Street NE
Mounds View,  MN  55112
Correspondent Contact Lisa Stone
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received09/26/2014
Decision Date 10/24/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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