Not Cleared Direct

everlinQ endoAVF System (DEN160006) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN160006 · Tva Medical, Inc. · Cardiovascular device
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Jun 2018
Decision
870d
Days
Class 2
Risk

DEN160006 is an FDA 510(k) submission (not cleared) for the everlinQ endoAVF System. Classified as Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access (product code PQK), Class II - Special Controls.

Submitted by Tva Medical, Inc. (Austin, US). The FDA issued a Not Cleared (DENG) decision on June 22, 2018 after a review of 870 days.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1252 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 870 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Tva Medical, Inc. devices

Submission Details

510(k) Number DEN160006 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received February 03, 2016
Decision Date June 22, 2018
Days to Decision 870 days
Submission Type Direct
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
745d slower than avg
Panel avg: 125d · This submission: 870d
Pathway characteristics

Device Classification

Product Code PQK Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1252
Definition Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access. This Device Is A Single Use Percutaneous Catheter System That Creates An Arteriovenous Fistula In The Arm Of Patients With Chronic Kidney Disease Who Need Hemodialysis.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - PQK Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access

Devices cleared under the same product code (PQK) and FDA review panel - the closest regulatory comparables to DEN160006.
WavelinQ Plus EndoAVF System
K192239 · C.R. Bard, Inc. · Oct 2019
Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle
K191114 · Avenu Medical · Aug 2019
WavelinQ 4F EndoAVF System
K182796 · C.R. Bard, Inc. · Feb 2019
Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle
K183615 · Avenu Medical, Inc. · Jan 2019
Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005)
K181725 · Avenu Medical, Inc. · Oct 2018
Ellipsys Vascular Access System
DEN170004 · Avenu Medical, Inc. · Jun 2018