A sterile, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip, and to simultaneously release a d
| Company | Devices | Share |
|---|---|---|
| Lutonix, Inc. | 182 | 32% |
| Medtronic, Inc. | 171 | 30% |
| Boston Scientific Corporation | 156 | 27% |
| Philips Image Guided Therapy Corporation | 42 | 7% |
| Surmodics, Inc. | 22 | 4% |
Company = labeler of record on GUDID. 5 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 |
|---|---|---|
| ONU | Drug-Eluting Peripheral Transluminal Angioplasty Catheter | 714 |
| PRC | Drug-coated peripheral transluminal angioplasty catheter | 265 |
| OUR | Sacroiliac joint fixation | 1 |
Use these as the dimensions to specify in a tender line.
573 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Peripheral angioplasty balloon catheter, drug-coated", from 5 companies. The largest labeler is Lutonix, Inc. with 32% of records.
ONU (Drug-Eluting Peripheral Transluminal Angioplasty Catheter), PRC (Drug-coated peripheral transluminal angioplasty catheter), OUR (Sacroiliac joint fixation)
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.