# PQK: Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access

- Device class: 2; regulation: 21 CFR 870.1252; FDA's rule: 510(k) required
- FDA decisions: 7
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2018: 3
- 2019: 4

## Most-cited predicates
- DEN170004: Ellipsys Vascular Access System (2018), cited by 1
- K181725: Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005) (2018), cited by 1
- K183615: Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle (2019), cited by 1
- DEN160006: everlinQ endoAVF System (2018), cited by 1
- K182796: WavelinQ 4F EndoAVF System (2019), cited by 1

Source page: https://510kreport.com/product-code/PQK
Data by year (CSV): https://510kreport.com/product-code/PQK.csv