PMA · Approved
Recalled · Class II · 2018Angiosculpt Scoring Balloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectranetics Corp. · NWX Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
Approved on Jan 8, 2007 through premarket approval, which rests on the device’s own clinical evidence after a 607-day review. It has been recalled 3 times.
- Decided
- Jan 8, 2007
- Review
- 607 days
- Class
- Class III
- Product code
- NWX
- Recalls
- 3
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P050018 has 32 supplements since 2007: 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 |
|---|---|
| 2007 | 3 |
| 2008 | 1 |
| 2009 | 4 |
| 2010 | 2 |
| 2011 | 5 |
| 2013 | 3 |
| 2016 | 2 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 2 |
| 2021 | 2 |
| 2023 | 2 |
| 2024 | 1 |
| 2025 | 2 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 7, 2018 | Class II | Z-0576-2020 | Process control | The incorrect outer carton box was used for the product. |
| Dec 4, 2009 | Not classified | Z-2218-2010 | Process design | Separations of the PTCA catheter shaft at the guide wire exit port have occurred during treatment of coronary artery stenosis. Fragments of the catheter may become lodged in coronary arteries, which resulting in serious patient outcome… |
| Nov 13, 2007 | Not classified | Z-0591-2008 | Process control | Mis-labeling: Product labeling on product pouch indicates wrong size, the correct size is on the product carton |
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. 2007, 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/P050018 · printed Nov 6, 2026
Cite this page
510(k) Report. “P050018: Angiosculpt Scoring Balloon Catheter.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P050018
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026