# DEN160006: everlinQ endoAVF System

- Pathway: De Novo (Direct)
- Applicant: Tva Medical, Inc.
- Decided: Jun 22, 2018 after 870 days
- Product code: PQK (Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access)
- Device class: 2
- Regulation: 21 CFR 870.1252
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K182796: WavelinQ 4F EndoAVF System (2019), 1 descendant of its own
- K192239: WavelinQ Plus EndoAVF System (2019), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/DEN160006
Methodology: https://510kreport.com/methodology