FDA product code · Cardiovascular
Iliac Covered Stent, Arterial
3 FDA decisions since 2017. 4 recalls name this code, 0 of them Class I.
For the treatment of de novo or restenotic lesions found in iliac arteries
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of PRL 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 · PRL
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PRL
Too few PRL 510(k)s in any year since 2007 to give a median.
Recalls per year · PRL
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PRL
451in 2025
MAUDE reports naming product code PRL, 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 | 7 | — | 0 | 91 |
| 2018 | 14 | — | 0 | 102 |
| 2019 | 9 | — | 1 | 99 |
| 2020 | 6 | — | 0 | 184 |
| 2021 | 5 | — | 1 | 235 |
| 2022 | 6 | — | 0 | 287 |
| 2023 | 9 | — | 1 | 303 |
| 2024 | 8 | — | 1 | 447 |
| 2025 | 9 | — | 0 | 451 |
| 2026 | 4 | — | 0 | — |
Planning a device in PRL? 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