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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name esophageal protection device for use in percutaneous cardiac catheter ablation procedures, mechanical deviation
De Novo Number DEN230006
Device Name esolution
Requester
s4 medical corp
34 s main street suite 200
chagrin falls,  OH  44022
Contact william fuller
Regulation Number870.5710
Classification Product Code
QXU  
Date Received01/24/2023
Decision Date 09/06/2023
Decision granted (DENG)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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