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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 K221373
Device Name Essenz HLM
Applicant
LivaNova Deutschland GmbH
Lindberghstr. 25
Munich,  DE 80939
Applicant Contact Julia E. Leslie
Correspondent
LivaNova Deutschland GmbH
Lindberghstr. 25
Munich,  DE 80939
Correspondent Contact Julia E. Leslie
Regulation Number870.4220
Classification Product Code
DTQ  
Date Received05/12/2022
Decision Date 03/09/2023
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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