FDA product code · Cardiovascular
Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access
7 FDA decisions since 2018. No recall names this code. The most-cited predicate is DEN170004, named by 1 later device.
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.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of PQK at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
FDA decisions per year · PQK
4in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · PQK
82in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PQK
No recall names PQK since 2007.
Adverse event reports per year · PQK
44in 2025
MAUDE reports naming product code PQK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 3 | — | 0 | 3 |
| 2019 | 4 | 82 | 0 | 51 |
| 2020 | 0 | — | 0 | 61 |
| 2021 | 0 | — | 0 | 74 |
| 2022 | 0 | — | 0 | 77 |
| 2023 | 0 | — | 0 | 71 |
| 2024 | 0 | — | 0 | 78 |
| 2025 | 0 | — | 0 | 44 |
| 2026 | 0 | — | 0 | — |
Planning a device in PQK? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report