Data / Medical devices / Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring (NWX): 4 FDA-registered makers in 3 countries
4 establishments in 3 countries are registered with the FDA to make Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring (product code NWX, Class 3). 4 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NWX
- Device class
- 3
- Medical specialty
- Unknown
Makers by country
| Country | Makers |
|---|---|
| United States | 2 |
| Ireland | 1 |
| China | 1 |
Makers of Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Boston Scientific Limited | GALWAY Galway(County), Ireland | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| OrbusNeich Medical (Shenzhen) Co., Ltd. | SHENZHEN Guangdong, China | Complaint file establishment, Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Spectranetics Corp. | Fremont, CA, United States | Complaint file establishment, Manufacturer | 0 | 1 | 3 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.