St. Louis, MO, US · 4 510(k) clearances · 2 PMAs · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | Class II | Cardiovascular | 1 | 2026-04-01 |
| DXX | System, Catheter Control, Steerable | Class II | Cardiovascular | 1 | 2025-11-06 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | Class II | Cardiovascular | 1 | 2025-07-23 |
| PJB | Catheter Remote Control System | Class II | Cardiovascular | 1 | 2020-03-05 |
| Date | PMA # | Trade name | Type | Code | Device name | Specialty |
|---|---|---|---|---|---|---|
| 2026-07-31 | P240014-S001 | MAGiC Ablation Catheter | Normal 180 Day Track No User Fee | LPB | Cardiac Ablation Percutaneous Catheter | Unknown |
| 2026-01-05 | P240014 | MAGiC Ablation Catheter | Original | LPB | Cardiac Ablation Percutaneous Catheter | Unknown |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2020-09-21 | Class II | Terminated | Z-0430-2021 | Niobe ES System, Models 001-006000-1 and 001-006100-1 | — | There is a potential for fire in the inside computer cabinet. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-04-01 | K253473 | Synchrony | DQK | Class II | Cardiovascular |
| 2025-11-06 | K251792 | Stereotaxis GenesisX RMN with Navigant Workstation (NWS) | DXX | Class II | Cardiovascular |
| 2025-07-23 | K250590 | MAGiC Sweep EP Mapping Catheter | DRF | Class II | Cardiovascular |
| 2020-03-05 | K193147 | Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System | PJB | Class II | Cardiovascular |