Redwood City, CA, US · 5 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| PDU | Catheter For Crossing Total Occlusions | Class II | Cardiovascular | 3 | 2023-04-25 |
| MCW | Catheter, Peripheral, Atherectomy | Class II | Cardiovascular | 2 | 2023-06-06 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2023-06-06 | K230005 | Pantheris LV Atherectomy Catheter | MCW | Class II | Cardiovascular |
| 2023-04-25 | K230594 | Tigereye ST CTO-Crossing Catheter | PDU | Class II | Cardiovascular |
| 2022-01-06 | K212468 | Tigereye CTO-Crossing Catheter | PDU | Class II | Cardiovascular |
| 2021-11-16 | K212047 | Pantheris System | MCW | Class II | Cardiovascular |
| 2020-09-10 | K201330 | Tigereye CTO-Crossing Catheter | PDU | Class II | Cardiovascular |