FDA product code · Cardiovascular
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
4 FDA decisions since 2000. 3 recalls name this code, 0 of them Class I.
To reduce coronary artery stenosis by dilatation of the balloon and by apposition of the cutting/scoring surfaces to the stenotic material for the treatment of coronary artery stenosis to improve myocardial perfusion.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of NWX 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 · NWX
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NWX
Too few NWX 510(k)s in any year since 2007 to give a median.
Recalls per year · NWX
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NWX
988in 2025
MAUDE reports naming product code NWX, 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 | 4 | — | 1 | 0 |
| 2008 | 4 | — | 0 | 3 |
| 2009 | 4 | — | 1 | 17 |
| 2010 | 2 | — | 0 | 15 |
| 2011 | 5 | — | 0 | 32 |
| 2012 | 1 | — | 0 | 26 |
| 2013 | 4 | — | 0 | 20 |
| 2014 | 0 | — | 0 | 14 |
| 2015 | 0 | — | 0 | 203 |
| 2016 | 8 | — | 0 | 324 |
| 2017 | 9 | — | 0 | 351 |
| 2018 | 6 | — | 1 | 463 |
| 2019 | 7 | — | 0 | 708 |
| 2020 | 15 | — | 0 | 728 |
| 2021 | 7 | — | 0 | 794 |
| 2022 | 16 | — | 0 | 754 |
| 2023 | 13 | — | 0 | 835 |
| 2024 | 7 | — | 0 | 882 |
| 2025 | 10 | — | 0 | 988 |
| 2026 | 5 | — | 0 | — |
Planning a device in NWX? 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