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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 temporary catheter, embolic protection, transcatheter intracardiac procedures
De Novo Number DEN160043
Device Name Sentinel Cerebral Protection System
Requester
claret medical, inc.
1745 copperhill parkway, suite 1
santa rosa,  CA  95403
Contact zachary woodson
Regulation Number870.1251
Classification Product Code
PUM  
Date Received09/20/2016
Decision Date 06/01/2017
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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