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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controller, Temperature, Cardiopulmonary Bypass
510(k) Number K220635
FOIA Releasable 510(k) K220635
Device Name Heater-Cooler System 3T
Applicant
Livanova Deutschland, GmbH
Lindbergh Strasse 25
Munchen,  DE 80939
Applicant Contact Julia E. Leslie
Correspondent
Livanova Deutschland, GmbH
Lindbergh Strasse 25
Munchen,  DE 80939
Correspondent Contact Julia E. Leslie
Regulation Number870.4250
Classification Product Code
DWC  
Date Received03/04/2022
Decision Date 11/16/2022
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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