FDA product code · Cardiovascular
Stent Graft, Bypass, Superficial Femoral Artery
1 FDA decision since 2023. No recall names this code.
For bypassing stenosis in the superficial femoral artery via the femoral vein
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of QWM 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 · QWM
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QWM
Too few QWM 510(k)s in any year since 2007 to give a median.
Recalls per year · QWM
No recall names QWM since 2007.
Adverse event reports per year · QWM
8in 2025
MAUDE reports naming product code QWM, 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 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 16 |
| 2025 | 5 | — | 0 | 8 |
| 2026 | 2 | — | 0 | — |
Planning a device in QWM? 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