Catheter Remote Control System
FDA product code PJB · Class II (moderate risk) · 21 CFR 870.5700 · Cardiovascular
A steerable cardiac ablation catheter remote control system is a device that is external to the body and interacts with the manual handle of a steerable cardiac ablation catheter to remotely control the advancement, retraction, rotation, and deflection of a steerable ablation catheter used for the treatment of cardiac arrhythmias in the right side of the heart. The device allows reversion to manual control of the steerable cardiac ablation catheter without withdrawal of the catheter and interruption of the procedure.
3510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K193147 | Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive SystemPJB · Traditional | Stereotaxis, Inc. | 03/05/2020SE |
| K192775 | Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and CardiodriPJB · Special | Stereotaxis, Inc. | 10/30/2019SE |
| K183027 | Steerable catheter control systemPJB · Traditional | Stereotaxis, Inc. | 09/06/2019SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0430-2021 Class II | Niobe ES System, Models 001-006000-1 and 001-006100-1There is a potential for fire in the inside computer cabinet. | Stereotaxis Inc | 09/21/2020Terminated |