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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 K112587
Device Name ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR,
Applicant
Terumo Cardiovascular Systems Corp.
6200 Jackson Rd.
Ann Arbor,  MI  48103
Applicant Contact REBECCA ANDERSEN
Correspondent
Terumo Cardiovascular Systems Corp.
6200 Jackson Rd.
Ann Arbor,  MI  48103
Correspondent Contact REBECCA ANDERSEN
Regulation Number870.4370
Classification Product Code
DWB  
Date Received09/06/2011
Decision Date 12/19/2011
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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