A sterile, flexible tube designed for use in percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery and increase myocardial perfusion, by controlled inflation of a distensible balloon at its distal tip with peripheral cuttin
| Company | Devices | Share |
|---|---|---|
| Spectranetics Corporation | 38 | 35% |
| Boston Scientific Corporation | 27 | 25% |
| Orbusneich Medical (Shenzhen) Co., Ltd. | 24 | 22% |
| Philips Image Guided Therapy Corporation | 16 | 15% |
| Venturemed Group, Inc. | 3 | 3% |
| Avalign Technologies, Inc. | 2 | 2% |
Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| NWX | Catheter, percutaneous transluminal coronary angioplasty (pt | 108 |
| NWX | Catheter, Percutaneous Transluminal Coronary Angioplasty (Pt | 80 |
| PNO | Catheter, Percutaneous, Cutting/Scoring | 3 |
| NBH | Accessories, Arthroscopic | 2 |
Use these as the dimensions to specify in a tender line.
110 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Coronary angioplasty balloon catheter, cutting/scoring", from 6 companies. The largest labeler is Spectranetics Corporation with 35% of records.
NWX (Catheter, percutaneous transluminal coronary angioplasty (pt), NWX (Catheter, Percutaneous Transluminal Coronary Angioplasty (Pt), PNO (Catheter, Percutaneous, Cutting/Scoring), NBH (Accessories, Arthroscopic)
No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.
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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.