# K073225: Sensei Catheter Control System

- Pathway: 510(k) (Traditional)
- Applicant: Hansen Medical, Inc.
- Decided: Jun 30, 2008 after 228 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: 4 generations back to K900765 (1990). 6 ancestors in all.
24 later devices descend from it; 2 cite it directly.
0 of 31 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.

## Most influential descendants
- K090365: Hansen Medical Artisan S Control Catheter (2009), 22 descendants of its own
- 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

## Recalls of this device
- Dec 4, 2014 · Class II · Z-0896-2015: The Set Up Joint subassembly of the Sensei X Robotic Catheter System may become loose relative to the operating table with the potential for the device to fall causing, uncontrolled catheter movement.

## Indications for use
The Sensei Robotic Catheter System, Artisan Catheter, and accessories are 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.

Source page: https://510kreport.com/device/K073225
Methodology: https://510kreport.com/methodology