FDA product code · Cardiovascular
Drug-Eluting Peripheral Transluminal Angioplasty Catheter
6 FDA decisions since 2014. 1 recall names this code; it is not Class I.
A drug-eluting peripheral transluminal angioplasty catheter is a combination product intended for balloon dilatation of peripheral vasculature to establish or maintain patency. A drug-eluting PTA catheter delivers a drug to the vessel as part of the angioplasty procedure and is intended to inhibit restenosis. Intended to provide percutaneous transluminal angioplasty of lesions in peripheral arteries including…
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of ONU 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 · ONU
18in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ONU
Too few ONU 510(k)s in any year since 2007 to give a median.
Recalls per year · ONU
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ONU
425in 2025
MAUDE reports naming product code ONU, 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 | 2 | — | 0 | 0 |
| 2015 | 17 | — | 0 | 478 |
| 2016 | 23 | — | 0 | 492 |
| 2017 | 14 | — | 0 | 590 |
| 2018 | 12 | — | 0 | 545 |
| 2019 | 15 | — | 0 | 1,054 |
| 2020 | 16 | — | 0 | 454 |
| 2021 | 21 | — | 0 | 306 |
| 2022 | 20 | — | 1 | 361 |
| 2023 | 20 | — | 0 | 485 |
| 2024 | 23 | — | 0 | 432 |
| 2025 | 18 | — | 0 | 425 |
| 2026 | 14 | — | 0 | — |
Planning a device in ONU? 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