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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 K172220
Device Name Advanced Perfusion System 1
Applicant
Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor,  MI  48103
Applicant Contact Bryan K. Hann
Correspondent
Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor,  MI  48103
Correspondent Contact Bryan K. Hann
Regulation Number870.4220
Classification Product Code
DTQ  
Subsequent Product Codes
DWB   KFM  
Date Received07/24/2017
Decision Date 08/17/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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