# K122488: Amigo Remote Catheter System & Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Catheter Robotics, Inc.
- Decided: Nov 20, 2012 after 97 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: 5 generations back to K900765 (1990). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113628: Amigo Remote Catheter System (RCS) & Accessories, Catheter Robotics, Inc. (2012)

## Indications for use
The Amigo Remote Catheter System (Amigo) 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 CATHETERS OTHER THAN the Boston Scientific Blazer® Dx-20 and Biosense Webster EZ STEER"' diagnostic catheters has not been established.

Source page: https://510kreport.com/device/K122488
Methodology: https://510kreport.com/methodology