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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reservoir, Blood, Cardiopulmonary Bypass
510(k) Number K141233
Device Name AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSUFACE
Applicant
Medtronic, Inc.
7611 Northland Dr.
Minneapolis,  MN  55428
Applicant Contact JESSICA SIXBERRY
Correspondent
Medtronic, Inc.
7611 Northland Dr.
Minneapolis,  MN  55428
Correspondent Contact JESSICA SIXBERRY
Regulation Number870.4400
Classification Product Code
DTN  
Subsequent Product Codes
DTP   JOD  
Date Received05/13/2014
Decision Date 06/12/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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