Salt Lake City, UT, US · 7 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| PNO | Catheter, Percutaneous, Cutting/Scoring | Class II | Cardiovascular | 3 | 2024-06-17 |
| DQY | — | — | — | 3 | 2022-04-11 |
| KRA | — | — | — | 1 | 2023-11-29 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2024-06-17 | K232258 | XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter | PNO | Class II | Cardiovascular |
| 2023-11-29 | K231821 | XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,) | KRA | — | — |
| 2022-10-18 | K221986 | XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter | PNO | Class II | Cardiovascular |
| 2022-04-11 | K214107 | XO CROSS CORONARY Support Catheter | DQY | — | — |
| 2021-10-21 | K210322 | XO Cross Support Catheter | DQY | — | — |
| 2020-05-29 | K193495 | XO Score Percutaneous Transluminal Angioplasty Scoring Catheter | PNO | Class II | Cardiovascular |
| 2020-05-06 | K193420 | XO Cross Support Catheter | DQY | — | — |