A sterile, flexible tube designed for use in percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible balloon. The tube contains holes proximal and distal to the balloon that permit blo
| Company | Devices | Share |
|---|---|---|
| Kossel Medtech (Suzhou) Co., Ltd. | 130 | 84% |
| Teleflex Incorporated | 21 | 14% |
| Shenzhen Antmed Co., Ltd | 3 | 2% |
Company = labeler of record on GUDID. 3 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 |
|---|---|---|
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | 128 |
| LOX | Catheters, transluminal coronary angioplasty, percutaneous | 21 |
| MAV | Syringe, Balloon Inflation | 3 |
| LOC | System, Rf/Microwave Hyperthermia, Cancer Treatment | 1 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 1 |
Use these as the dimensions to specify in a tender line.
154 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Coronary angioplasty balloon catheter, perfusing", from 3 companies. The largest labeler is Kossel Medtech (Suzhou) Co., Ltd. with 84% of records.
LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous), LOX (Catheters, transluminal coronary angioplasty, percutaneous), MAV (Syringe, Balloon Inflation), LOC (System, Rf/Microwave Hyperthermia, Cancer Treatment)
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.