FDA product code · Cardiovascular
Drug-Coated Peripheral Transluminal Angioplasty Catheter
2 FDA decisions since 2017. 1 recall names this code; it is not Class I.
Balloon dilatation of native and/or synthetic arteriovenous dialysis fistulae to establish or maintain patency
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of PRC 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 · PRC
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PRC
Too few PRC 510(k)s in any year since 2007 to give a median.
Recalls per year · PRC
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PRC
266in 2025
MAUDE reports naming product code PRC, 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 | 1 | — | 0 | 2 |
| 2018 | 4 | — | 0 | 11 |
| 2019 | 8 | — | 0 | 10 |
| 2020 | 10 | — | 0 | 16 |
| 2021 | 14 | — | 0 | 24 |
| 2022 | 6 | — | 1 | 27 |
| 2023 | 6 | — | 0 | 31 |
| 2024 | 7 | — | 0 | 65 |
| 2025 | 10 | — | 0 | 266 |
| 2026 | 6 | — | 0 | — |
Planning a device in PRC? 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