PJB
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Catheter Remote Control System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5700
- Medical specialty
- Cardiovascular
- FDA definition
- 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.
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| Record | Firm | Date |
|---|---|---|
| Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System (K193147) | Stereotaxis, Inc. | 2020-03-05 |
| Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri (K192775) | Stereotaxis, Inc. | 2019-10-30 |
| Steerable catheter control system (K183027) | Stereotaxis, Inc. | 2019-09-06 |
| AMIGO REMOTE CATHETER SYSTEM (DEN140009) | Catheter Robotics, Inc. | 2014-12-18 |
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