FDA product code · Cardiovascular
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
5 FDA decisions since 2007. No recall names this code.
An endovascular graft for AV dialysis access is a stent graft intended for the revision of arteriovenous access circuits to maintain or re-establish vascular access (treat stenotic lesions or thromboic occlusions) for 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 PFV 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 · PFV
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PFV
Too few PFV 510(k)s in any year since 2007 to give a median.
Recalls per year · PFV
No recall names PFV since 2007.
Adverse event reports per year · PFV
192in 2025
MAUDE reports naming product code PFV, 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 | 1 | — | 0 | 0 |
| 2008 | 3 | — | 0 | 0 |
| 2009 | 5 | — | 0 | 0 |
| 2010 | 7 | — | 0 | 0 |
| 2011 | 4 | — | 0 | 0 |
| 2012 | 5 | — | 0 | 0 |
| 2013 | 7 | — | 0 | 0 |
| 2014 | 17 | — | 0 | 1 |
| 2015 | 12 | — | 0 | 54 |
| 2016 | 14 | — | 0 | 82 |
| 2017 | 13 | — | 0 | 195 |
| 2018 | 17 | — | 0 | 343 |
| 2019 | 13 | — | 0 | 376 |
| 2020 | 12 | — | 0 | 337 |
| 2021 | 12 | — | 0 | 281 |
| 2022 | 8 | — | 0 | 261 |
| 2023 | 9 | — | 0 | 229 |
| 2024 | 5 | — | 0 | 209 |
| 2025 | 11 | — | 0 | 192 |
| 2026 | 5 | — | 0 | — |
Planning a device in PFV? 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