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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 percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access
De Novo Number DEN160006
Device Name everlinQ endoAVF System
Requester
tva medical, inc.
7000 bee cave rd
austin,  TX  78746
Contact noah bartsch
Regulation Number870.1252
Classification Product Code
PQK  
Date Received02/03/2016
Decision Date 06/22/2018
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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