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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 Number
870.1252
Classification Product Code
PQK
Date Received
02/03/2016
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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