510(k) K192775
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 30, 2019
- Date Received
- September 30, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter Remote Control System
- Device Class
- Class II
- Regulation Number
- 870.5700
- Review Panel
- CV
- Submission Type
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.