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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 reverse central venous recanalization system
De Novo Number DEN190038
Device Name Surfacer Inside-Out Access Catheter System
Requester
bluegrass vascular technologies, inc.
12500 network boulevard, suite 308
san antonio,  TX  78249
Contact gabriele g. niederauer
Regulation Number870.1342
Classification Product Code
QJH  
Date Received08/15/2019
Decision Date 02/10/2020
Decision granted (DENG)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
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