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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Blood, Cardiopulmonary Bypass, Roller Type
510(k) Number K162843
Device Name Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1
Applicant
Terumo Cardiovascular Systems Corporation
6200 Jackson Rd.
Ann Arbor,  MI  48103
Applicant Contact Bryan Hann
Correspondent
Terumo Cardiovascular Systems Corporation
6200 Jackson Rd.
Ann Arbor,  MI  48103
Correspondent Contact Bryan Hann
Regulation Number870.4370
Classification Product Code
DWB  
Date Received10/11/2016
Decision Date 11/17/2016
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
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