FDA product code · Cardiovascular
Stent, Superficial Femoral Artery, Drug-Eluting
2 FDA decisions since 2012. No recall names this code.
Stent, Superficial Femoral Artery, Drug-Eluting -- a metal scaffold with a drug coating placed via a delivery catheter into the superficial femoral artery artery to maintain the lumen. The drug coating is intended to inhibit restenosis.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of NIU 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 · NIU
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NIU
Too few NIU 510(k)s in any year since 2007 to give a median.
Recalls per year · NIU
No recall names NIU since 2007.
Adverse event reports per year · NIU
181in 2025
MAUDE reports naming product code NIU, 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 | 1 | — | 0 | 0 |
| 2013 | 8 | — | 0 | 20 |
| 2014 | 0 | — | 0 | 169 |
| 2015 | 6 | — | 0 | 168 |
| 2016 | 5 | — | 0 | 232 |
| 2017 | 4 | — | 0 | 279 |
| 2018 | 10 | — | 0 | 194 |
| 2019 | 20 | — | 0 | 295 |
| 2020 | 22 | — | 0 | 319 |
| 2021 | 9 | — | 0 | 225 |
| 2022 | 5 | — | 0 | 254 |
| 2023 | 7 | — | 0 | 248 |
| 2024 | 7 | — | 0 | 175 |
| 2025 | 4 | — | 0 | 181 |
| 2026 | 4 | — | 0 | — |
Planning a device in NIU? 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