Dongguan, CN · 5 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | Class II | Cardiovascular | 2 | 2025-02-27 |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | Class II | Cardiovascular | 2 | 2023-04-11 |
| PNO | Catheter, Percutaneous, Cutting/Scoring | Class II | Cardiovascular | 1 | 2024-10-22 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-02-27 | K243704 | Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter | LIT | Class II | Cardiovascular |
| 2024-10-22 | K241478 | Tri-Wedge PTA Scoring Balloon Dilatation Catheter | PNO | Class II | Cardiovascular |
| 2023-04-11 | K230705 | POT PTCA Balloon Dilatation Catheter | LOX | Class II | Cardiovascular |
| 2022-07-19 | K212215 | Tiche PTA Balloon Dilatation Catheter | LIT | Class II | Cardiovascular |
| 2021-04-14 | K203390 | Artimes pro Balloon Dilatation Catheter | LOX | Class II | Cardiovascular |