# K122275: Artisan Extend Control Catheter

- Pathway: 510(k) (Special)
- Applicant: Hansen Medical
- Decided: Aug 29, 2012 after 30 days
- Product code: DRA (Catheter, Steerable)
- Device class: 2
- Regulation: 21 CFR 870.1280
- 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)
- K073225: Sensei Catheter Control System, Hansen Medical, Inc. (2008) Summary page 1.

## Indications for use
The Hansen Medical Artisan Extend Control Catheter is intended to facilitate manipulation, positioning and control, for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems, using the following percutaneous mapping catheters: the Polaris-DxTM Steerable Diagnostic catheters made by Boston Scientific Corporation and the Livewire TM Electrophysiology catheters made by St. Jude Medical. The Artisan Extend Control Catheter is intended to be used with the Hansen Medical Sensei® X Robotic Catheter System.

Source page: https://510kreport.com/device/K122275
Methodology: https://510kreport.com/methodology