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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Defoamer, Cardiopulmonary Bypass
510(k) Number K101186
Device Name AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG
Applicant
Medtronic Perfusion Systems
7611 Northland Dr.
Minneapolis,  MN  55432
Applicant Contact CARALEE WALTON
Correspondent
Medtronic Perfusion Systems
7611 Northland Dr.
Minneapolis,  MN  55432
Correspondent Contact CARALEE WALTON
Regulation Number870.4230
Classification Product Code
DTP  
Date Received04/28/2010
Decision Date 09/03/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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