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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name filter, blood, cardiopulmonary bypass, arterial line
510(k) Number K122760
Device Name AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE
Original Applicant
MEDTRONIC INC.
7611 northland drive
minneapolis,  MN  55428
Original Contact julia a nelson
Regulation Number870.4260
Classification Product Code
DTM  
Date Received09/10/2012
Decision Date 12/07/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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