A flexible tube with a drug coating at its distal end designed for percutaneous transluminal coronary angioplasty (PTCA) to dilate an atherosclerotic stenotic coronary artery by controlled inflation of a distal distensible balloon, and to simultaneously releas
| Company | Devices | Share |
|---|---|---|
| Medalliance, Llc | 32 | 53% |
| Boston Scientific Corporation | 28 | 47% |
Company = labeler of record on GUDID. 2 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 |
|---|---|---|
| OOB | Drug-Eluting Percutaneous Transluminal Coronary Angioplasty | 32 |
| OOB | Drug-eluting percutaneous transluminal coronary angioplasty | 28 |
Use these as the dimensions to specify in a tender line.
60 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Coronary angioplasty balloon catheter, drug-coated", from 2 companies. The largest labeler is Medalliance, Llc with 53% of records.
OOB (Drug-Eluting Percutaneous Transluminal Coronary Angioplasty ), OOB (Drug-eluting percutaneous transluminal coronary angioplasty )
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.