510(k) Report

De Novo · Granted

Granted

everlinQ endoAVF System

DEN160006De NovoGranted Jun 22, 2018870-day reviewClass II21 CFR 870.1252

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Tva Medical, Inc. · PQK Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access

Granted on Jun 22, 2018 as a new device type through De Novo after an 870-day review. 2 later devices descend from it.

Decided
Jun 22, 2018
Review
870 days
Class
Class II
Product code
PQK
Recalls
None

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2019: 2 descendants cleared201620182020202220242026
  1. This deviceDEN160006 everlinQ endoAVF SystemTva Medical, Inc. · 2018
  2. Descendant · cites it directly · 1 of its ownK182796 WavelinQ 4F EndoAVF SystemC.R. Bard, Inc. · 2019 · Recalled
  3. Descendant · 2 generations on · 0 of its ownK192239 WavelinQ Plus EndoAVF SystemC.R. Bard, Inc. · 2019 · Recalled

Most influential descendants

Showing 2 of 2 · See all
  • K182796WavelinQ 4F EndoAVF SystemC.R. Bard, Inc. · 2019 · cites it directly1descendant
  • K192239WavelinQ Plus EndoAVF SystemC.R. Bard, Inc. · 2019 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)DEN160006everlinQ endoAVF SystemTva Medical, Inc.2018—
+1K182796WavelinQ 4F EndoAVF SystemC.R. Bard, Inc.20191
+2K192239WavelinQ Plus EndoAVF SystemC.R. Bard, Inc.20191

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201920
FIG. 1 — Lineage of DEN160006, 2018–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in PQK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

Does it have a predicate?

De Novo decisions do not claim a predicate device.

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K182796WavelinQ 4F EndoAVF SystemC.R. Bard, Inc.20191

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K182796 (C.R. Bard, Inc., 2019) has gone furthest, with 1 descendant of its own.

How does its category compare?

All PQK devices

PQK Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · PQK

4in 2019

2018: 32019: 4
2007high 4 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PQK

82in 2019

2019: 82 days median
2007high 82 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · PQK

No recall names PQK since 2007.

Adverse event reports per year · PQK

44in 2025

2018: 32019: 512020: 612021: 742022: 772023: 712024: 782025: 44
2007high 78 (2024) · low 0 (2007)2025

MAUDE reports naming product code PQK, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20183—03
2019482051
20200—061
20210—074
20220—077
20230—071
20240—078
20250—044
20260—0—

What is it indicated for?

The everlinQ endoAVF System is indicated for the creation of an arteriovenous fistula (AVF) using the ulnar artery and ulnar vein in patients with minimum artery and vein diameters of 2.0 mm and less than 2.0 mm separation between the artery and vein at the fistula creation site who have chronic kidney disease and need hemodialysis.

Indications for use as stated in the FDA summary.

More from Tva Medical, Inc.

2 FDA decisions under this applicant name. See the company

  • K162656ESU-1 Electrosurgical GeneratorTva Medical, Inc. · 2016

Recent decisions in PQK

The PQK category page

  • K192239WavelinQ Plus EndoAVF SystemC.R. Bard, Inc. · 20191 recall
  • K191114Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System…Avenu Medical · 2019
  • K182796WavelinQ 4F EndoAVF SystemC.R. Bard, Inc. · 20191 recall
  • K183615Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System…Avenu Medical, Inc. · 2019
  • K181725Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle…Avenu Medical, Inc. · 2018

https://510kreport.com/device/DEN160006 · printed Nov 6, 2026

Cite this page

510(k) Report. “DEN160006: everlinQ endoAVF System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN160006

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026