510(k) DEN140009
DEN140009 is an FDA 510(k) premarket notification submitted by Catheter Robotics, Inc. for the device "AMIGO REMOTE CATHETER SYSTEM". The FDA issued a decision of De Novo Granted on December 18, 2014. The device falls under product code PJB (Catheter Remote Control System), a Class II device regulated under 21 CFR 870.5700. Catheter Robotics, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- December 18, 2014
- Date Received
- February 18, 2014
- Clearance Type
- Direct
- 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.