# K052480: Hansen Medical Catheter Control System (CCS) and Accessories, Hansen Medical Steerable Guide Catheter (SGC) and Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Hansen Medical, Inc.
- Decided: May 2, 2007 after 600 days
- Product code: DXX (System, Catheter Control, Steerable)
- Device class: 2
- Regulation: 21 CFR 870.1290
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K900765 (1990). 5 ancestors in all.
27 later devices descend from it; 2 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021555: Stereotaxis Niobe Magnetic Navigation System, Stereotaxis, Inc. (2003) Summary page 1.

## Most influential descendants
- K073225: Sensei Catheter Control System (2008), 24 descendants of its own
- 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

## 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.
- May 21, 2008 · Not classified · Z-2106-2008: The catheter's flexible bellows portion may develop a leak. This has the potential to cause loss of hemostasis, flush fluid leakage, and/or introduction of air into the catheter with a risk of subsequ

## Indications for use
The Hansen Medical Catheter Control System, Steerable Guide Catheter, Sheath, 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-DxTM Steerable Diagnostic catheters made by Boston Scientific Corporation and the LivewireTM Electrophysiology catheters made by St. Jude Medical.

Source page: https://510kreport.com/device/K052480
Methodology: https://510kreport.com/methodology