FDA product code · Cardiovascular
Scaffold, Dissection Repair
2 FDA decisions since 2019. 1 recall names this code; it is Class I.
For the repair of dissections following percutaneous transluminal angioplasty in the lower extremity 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 QCT 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 · QCT
5in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · QCT
Too few QCT 510(k)s in any year since 2007 to give a median.
Recalls per year · QCT
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · QCT
1in 2025
MAUDE reports naming product code QCT, 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 | 1 | — | 0 | 1 |
| 2020 | 5 | — | 0 | 3 |
| 2021 | 3 | — | 0 | 6 |
| 2022 | 5 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 464 |
| 2025 | 0 | — | 1 (1) | 1 |
| 2026 | 0 | — | 0 | — |
Planning a device in QCT? 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