EverlinQ EndoAVF System

Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access

TVA Medical, Inc.

The following data is part of a De Novo classification by Tva Medical, Inc. with the FDA for Everlinq Endoavf System.

Pre-market Notification Details

DeNovo IDDEN160006
Device Name:EverlinQ EndoAVF System
ClassificationPercutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access
Applicant TVA Medical, Inc. 7000 Bee Cave Rd Austin,  TX  78746
ContactNoah Bartsch
Product CodePQK  
CFR Regulation Number870.1252 [🔎]
DecisionGranted (DENG)
501(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardCardiovascular
Classification AdvisoryCardiovascular
TypeDirect
Date Received2016-02-03
Decision Date2018-06-22
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00868260000211 DEN160006 000

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