Shenzhen, CN · 5 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| FPA | Set, Administration, Intravascular | Class II | General Hospital | 2 | 2023-12-01 |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | Class II | Cardiovascular | 2 | 2021-05-06 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Class II | Gastroenterology, Urology | 1 | 2021-04-09 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2023-12-01 | K230528 | Extension Set | FPA | Class II | General Hospital |
| 2022-05-10 | K213004 | Needle Free Connector | FPA | Class II | General Hospital |
| 2021-05-06 | K202578 | KardiFlex NC Coronary Dilatation Catheter | LOX | Class II | Cardiovascular |
| 2021-04-29 | K202619 | KardiFlex PTCA Balloon Dilatation Catheter | LOX | Class II | Cardiovascular |
| 2021-04-09 | K202748 | Enteral Feeding Catheter | KNT | Class II | Gastroenterology, Urology |