PMA · Approved
ApprovedLacrosse NSE ALPHA Coronary Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Goodman Co., Ltd. · NWX Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
Approved on Jun 6, 2024 through premarket approval, which rests on the device’s own clinical evidence after a 280-day review.
- Decided
- Jun 6, 2024
- Review
- 280 days
- Class
- Class III
- Product code
- NWX
- Recalls
- None
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P230026 has 4 supplements since 2024: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2024 | 1 |
| 2026 | 3 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NWX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All NWX devicesNWX Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
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 | — |
https://510kreport.com/device/P230026 · printed Nov 5, 2026
Cite this page
510(k) Report. “P230026: Lacrosse NSE ALPHA Coronary Dilatation Catheter.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/P230026
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026