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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 K221895
Device Name Terumo Advanced Perfusion System 1
Applicant
Terumo Cardiovascular Systems Corporation
6200 Jackson Rd.
Ann Arbor,  MI  48103
Applicant Contact Eileen Dorsey
Correspondent
Terumo Cardiovascular Systems Corporation
6200 Jackson Rd.
Ann Arbor,  MI  48103
Correspondent Contact Eileen Dorsey
Regulation Number870.4220
Classification Product Code
DTQ  
Date Received06/30/2022
Decision Date 04/18/2023
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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