# DEN140009: Amigo Remote Catheter System

- Pathway: De Novo (Direct)
- Applicant: Catheter Robotics, Inc.
- Decided: Dec 18, 2014 after 303 days
- Product code: PJB (Catheter Remote Control System)
- Device class: 2
- Regulation: 21 CFR 870.5700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K183027: Steerable catheter control system (2019), 2 descendants of its own
- K192775: Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri (2019), 1 descendant of its own
- K193147: Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System (2020), 0 descendants of its own

## Indications for use
to facilitate manipulation, positioning and control of compatible percutaneous electrophysiological ablation catheters that deliver RF energy for treatment of cardiac arrhythmias in the right atrium. Use of Amigo RCS should also be in accordance with the indications for use of compatible ablation catheters. The Amigo RCS should only be used with the Boston Scientific catheters (with the BlazerTM handle) and/or the Biosense Webster catheters (with the EZ Steer® handle) in the right atrium

Source page: https://510kreport.com/device/DEN140009
Methodology: https://510kreport.com/methodology