# K192239: WavelinQ Plus EndoAVF System

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Oct 17, 2019 after 59 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: 2 generations back to DEN160006 (2018). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182796: WavelinQ 4F EndoAVF System, C.R. Bard, Inc. (2019) Summary page 4.

## Recalls of this device
- Jun 13, 2014 · Class II · Z-2085-2014: Partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. When connecting the PDM (Patient Data Module) to the CARESCAPE B850, B650 or B450 monitor with software version 2 the PDM may 

## Indications for use
The WavelinQ™ 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/K192239
Methodology: https://510kreport.com/methodology