PQK
7 FDA 510(k) clearances · Product code
105 daysmedian time to decision
870 days90th percentile
7clearances measured
FDA profile
- Official device name
- Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1252
- Medical specialty
- Cardiovascular
- FDA definition
- Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access. This device is a single use percutaneous catheter system that creates an arteriovenous fistula in the arm of patients with chronic kidney disease who need hemodialysis.
- Adverse events (MAUDE)
- 2021: 74 · 2022: 77 · 2023: 71 · 2024: 78 · 2025: 44 · 2026: 27
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| WavelinQ Plus EndoAVF System (K192239) | C.R. Bard, Inc. | 2019-10-17 |
| Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle (K191114) | Avenu Medical | 2019-08-09 |
| WavelinQ 4F EndoAVF System (K182796) | C.R. Bard, Inc. | 2019-02-06 |
| Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle (K183615) | Avenu Medical, Inc. | 2019-01-25 |
| Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005) (K181725) | Avenu Medical, Inc. | 2018-10-05 |
| Ellipsys Vascular Access System (DEN170004) | Avenu Medical, Inc. | 2018-06-22 |
| everlinQ endoAVF System (DEN160006) | Tva Medical, Inc. | 2018-06-22 |
Track PQK automatically
Every clearance here is in the API, with alerts when new ones post.