FDA product code · Cardiovascular
Stent, Iliac Vein
5 FDA decisions since 2019. 1 recall names this code; it is not Class I.
A metal scaffold placed via a delivery catheter in the iliac vein to maintain the lumen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of QAN 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 · QAN
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QAN
Too few QAN 510(k)s in any year since 2007 to give a median.
Recalls per year · QAN
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QAN
177in 2025
MAUDE reports naming product code QAN, 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 | 0 | — | 0 | 0 |
| 2019 | 4 | — | 0 | 24 |
| 2020 | 10 | — | 0 | 117 |
| 2021 | 11 | — | 1 | 425 |
| 2022 | 5 | — | 0 | 115 |
| 2023 | 7 | — | 0 | 208 |
| 2024 | 9 | — | 0 | 128 |
| 2025 | 5 | — | 0 | 177 |
| 2026 | 8 | — | 0 | — |
Planning a device in QAN? 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