# K141822: Sensei X Robotic Catheter System

- Pathway: 510(k) (Special)
- Applicant: Hanson Medical, Inc.
- Decided: Aug 5, 2014 after 29 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: 8 generations back to K900765 (1990). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102168: Sensei X Robotic Catheter System, Hansen Medical, Inc. (2010) Summary page 4.

## 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 Hansen Medical Sensei X Robotic Catheter System and Accessories are intended to facilitate manipulation, positioning and control of Hansen Medical’s robotically steerable catheters for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems, using the following percutaneous mapping catheters: the Polaris-Dx™ Steerable Diagnostic catheters made by Boston Scientific Corporation and the Livewire™ Electrophysiology catheters made by St. Jude Medical.

Source page: https://510kreport.com/device/K141822
Methodology: https://510kreport.com/methodology