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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 K123314
Device Name AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND CARMEDA BIOACTIVE SURFACE
Applicant
Medtronic, Inc.
7611 Northland Dr.
Minneapolis,  MN  55428
Applicant Contact MARY E DONLIN
Correspondent
Medtronic, Inc.
7611 Northland Dr.
Minneapolis,  MN  55428
Correspondent Contact MARY E DONLIN
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received10/25/2012
Decision Date 01/22/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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