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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 K151349
Device Name Advanced Perfusion System 1
Applicant
Terumo Cardiovascular Systems Corporation
6200 Jackson Rd.
Ann Arbor,  MI  48103
Applicant Contact John Chesney
Correspondent
Terumo Cardiovascular Systems Corporation
6200 Jackson Rd.
Ann Arbor,  MI  48103
Correspondent Contact John Chesney
Regulation Number870.4220
Classification Product Code
DTQ  
Date Received05/20/2015
Decision Date 08/27/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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