# K113628: Amigo Remote Catheter System (RCS) & Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Catheter Robotics, Inc.
- Decided: Jun 12, 2012 after 187 days
- Product code: DXX (System, Catheter Control, Steerable)
- Device class: 2
- Regulation: 21 CFR 870.1290
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K900765 (1990). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052480: Hansen Medical Catheter Control System (CCS) and Accessories, Hansen Medical Steerable Guide Catheter (SGC) and Sheath, Hansen Medical, Inc. (2007) Summary page 1.
- K021555: Stereotaxis Niobe Magnetic Navigation System, Stereotaxis, Inc. (2003) Summary page 1.

## Most influential descendants
- K122488: Amigo Remote Catheter System & Accessories (2012), 0 descendants of its own

## Indications for use
The Amigo Remote Catheter System (ROS) is intended to facilitate manipulation, positioning and control of percutaneous diagnostic catheters for stimulating cardiac tissue and for recording electrophysiological data in the right atrium and right ventricle. The safety and effectiveness of this device for ablation in the treatment of cardiac arrhythmias including atrial fibrillation, has not been established. The safety and effectiveness of this device for cardiac mapping when used with any catheter other than the Boston Scientific BlazerTm Dx-20 has not been established.

Source page: https://510kreport.com/device/K113628
Methodology: https://510kreport.com/methodology