# K090365: Hansen Medical Artisan S Control Catheter

- Pathway: 510(k) (Special)
- Applicant: Hansen Medical, Inc.
- Decided: May 7, 2009 after 83 days
- Product code: DXX (System, Catheter Control, Steerable)
- Device class: 2
- Regulation: 21 CFR 870.1290
- Recalls of this device: 1 (0 Class I)
- 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.
22 later devices descend from it; 2 cite it directly.
0 of 30 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.

## Most influential descendants
- K091808: Sensei Robotic Catheter System, Model 02057 (2009), 19 descendants of its own
- K102168: Sensei X Robotic Catheter System (2010), 12 descendants of its own
- K111004: Hansen Medical Vascular Catheter Control System and Catheter (2012), 10 descendants of its own
- K132369: Magellan Robotic System, Magellan Robotic Catheter 9FR (2013), 9 descendants of its own
- K120834: Corpath 200 System (2012), 8 descendants of its own

## Recalls of this device
- Oct 19, 2009 · Not classified · Z-1251-2010: Certain Artisan Extend Catheters may develop a leak in the flush assembly of the catheter which has the potential to cause flush fluid leakage and subsequent decrease in distal flush; inability to asp

## Indications for use
The Hansen Medical Artisan S 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-Dx TM Steerable Diagnostic catheters made by Boston Scientific Corporation and the Livewire TM Electrophysiology catheters made by St. Jude Medical. The Control Catheter is intended to be used with the Hansen Medical Sensei® Robotic Catheter System.

Source page: https://510kreport.com/device/K090365
Methodology: https://510kreport.com/methodology