Tokyo, JP · 5 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| DQX | Wire, Guide, Catheter | Class II | Cardiovascular | 2 | 2024-11-26 |
| LOX | — | — | — | 1 | 2026-03-27 |
| FMI | Needle, Hypodermic, Single Lumen | Class II | General Hospital | 1 | 2025-11-21 |
| DQO | — | — | — | 1 | 2025-07-17 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-03-27 | K252295 | Ryurei | LOX | — | — |
| 2025-11-21 | K250700 | Pen Injector Needle 32.5 | FMI | Class II | General Hospital |
| 2025-07-17 | K250751 | DualView Catheter | DQO | — | — |
| 2024-11-26 | K240818 | R2P Radifocus Glidewire Advantage | DQX | Class II | Cardiovascular |
| 2024-08-21 | K240859 | Glidewire GT-R | DQX | Class II | Cardiovascular |