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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name console, heart-lung machine, cardiopulmonary bypass
510(k) Number K131041
Model 801763 (100/120V), 801764 (220/240V)
Device Name ADVANCED PERFUSION SYSTEM 1
Original Applicant
TERUMO CARDIOVASCULAR SYSTEMS CORP.
6200 jackson rd.
ann arbor,  MI  48103
Original Contact mark bur
Regulation Number870.4220
Classification Product Code
DTQ  
Date Received04/16/2013
Decision Date 02/20/2014
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 No
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