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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 K122914
Model BB841, CB841
Device Name AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, AFFINITY FUSION CARDIOTOMY/ VENOUS RESE
Applicant
MEDTRONIC INC.
7611 northland drive
minneapolis,  MN  55428
Contact julia a nelson
Regulation Number870.4400
Classification Product Code
DTN  
Date Received09/21/2012
Decision Date 01/09/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product Yes
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