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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubing, Pump, Cardiopulmonary Bypass
510(k) Number K233702
Device Name SMARxT Tubing and Connectors
Applicant
Livanova USA Inc
14401 West 65th Way
Arvada,  CO  80004
Applicant Contact Tatjana Kuntschik
Correspondent
Livanova USA Inc
14401 West 65th Way
Arvada,  CO  80004
Correspondent Contact Tatjana Kuntschik
Regulation Number870.4390
Classification Product Code
DWE  
Date Received11/17/2023
Decision Date 08/08/2024
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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