# K182796: WavelinQ 4F EndoAVF System

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Feb 6, 2019 after 128 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN160006 (2018). 1 ancestor in all.
1 later device descends 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)
- DEN160006: everlinQ endoAVF System, Tva Medical, Inc. (2018) Summary page 4.

## Most influential descendants
- K192239: WavelinQ Plus EndoAVF System (2019), 0 descendants of its own

## Recalls of this device
- Apr 12, 2019 · Class II · Z-1637-2020: The firm has become aware of a potential problem with their venous and arterial magnetic catheters may be at risk of experiencing a magnetic deficiency, which may result in the magnets failing to attr

## Indications for use
The WavelinQ 4F EndoAVF System is indicated for the creation of an arteriovenous fistula (AVF) using concomitant ulnar artery and ulnar vein or concomitant radial artery and radial vein in patients with minimum artery and vein diameters of 2.0 mm at the fistula creation site who have chronic kidney disease and need hemodialysis.

Source page: https://510kreport.com/device/K182796
Methodology: https://510kreport.com/methodology