FDA product code · Cardiovascular
Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon
5 FDA decisions since 2005. 510(k) reviews decided 2021–2025 took a median of 35 days (half between 31 and 38). 1 recall names this code; it is not Class I. The most-cited predicate is K050857, named by 1 later device.
Percutaneous transluminal angioplasty of peripheral vasculature exclusive of coronary 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 NVM 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 · NVM
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · NVM
Too few NVM 510(k)s in any year since 2007 to give a median.
Recalls per year · NVM
No recall names NVM since 2007.
Adverse event reports per year · NVM
2in 2025
MAUDE reports naming product code NVM, 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 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
Planning a device in NVM? 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) ReportRelated product codes
Other codes under 21 CFR 870.1250.