Catheter Remote Control System
Cardiovascular · 21 CFR 870.5700
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 MDR events
6 adverse event reports on file
- STEREOTAXIS SYSTEMNov 7, 2025MalfunctionOmega Medical Imaging Inc. / Stereotaxis, Inc.MW5178641
- STEREOTAXISAug 29, 2023MalfunctionStereotaxis, Inc17641166
- STEREOTAXISJun 7, 2023MalfunctionStereotaxis, Inc17078300
- CARDIODRIVE MOTORMay 31, 2023MalfunctionStereotaxis, Inc17029987
- STEREOTAXIS GENESIS RMN WITH NAVIGANT WORKSTATION AND CARDIODRIVE SYSTEMMar 29, 2023MalfunctionStereotaxis, Inc.16634726
- STEREOTAXIS GENESIS RMN WITH NAVIGANT WORKSTATION AND CARDIODRIVE SYSTEMMar 29, 2023MalfunctionStereotaxis, Inc.16634745
Event type breakdown
Most-reported manufacturers
Registered firms
2 firms currently registered for this product code
510(k) clearances
4 clearances for this product code
- Stereotaxis, Inc.Mar 5, 2020
K193147 · Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System
- Stereotaxis, Inc.Oct 30, 2019
K192775 · Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri
- Stereotaxis, Inc.Sep 6, 2019
K183027 · Steerable catheter control system
- Catheter Robotics, Inc.Dec 18, 2014
DEN140009 · AMIGO REMOTE CATHETER SYSTEM