PJB — Catheter Remote Control System Class II
Classification Details
- Product Code
- PJB
- Device Class
- Class II
- Regulation Number
- 870.5700
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K193147 | stereotaxis | Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System | March 5, 2020 |
| K192775 | stereotaxis | Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Card | October 30, 2019 |
| K183027 | stereotaxis | Steerable catheter control system | September 6, 2019 |
| DEN140009 | catheter robotics | AMIGO REMOTE CATHETER SYSTEM | December 18, 2014 |