# K111004: Hansen Medical Vascular Catheter Control System and Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Hansen Medical, Inc.
- Decided: May 29, 2012 after 414 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: 8 generations back to K900765 (1990). 14 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080415: Device Modification to Pinnacle Destination Peripheral Guiding Sheath, Terumo Medical Corp. (2008) Summary page 1.
- K102168: Sensei X Robotic Catheter System, Hansen Medical, Inc. (2010) Summary page 1.

## Most influential descendants
- K132369: Magellan Robotic System, Magellan Robotic Catheter 9FR (2013), 9 descendants of its own
- K141614: Magellan Robotic System (2014), 5 descendants of its own
- K152999: CorPath 200 System (2016), 2 descendants of its own
- K133552: Magellan Robotic Catheter 6FR (Guide and Leader), Magellan Robotic Catheter 6FR Accessory Kit (2014), 2 descendants of its own
- K173288: CorPath GRX System (2018), 1 descendant of its own

## Recalls of this device
- Mar 25, 2016 · Class II · Z-1564-2016: Firm's quarterly dose audit testing showed that one batch was radiated below the augmented dose and therefore did not meet the augmented dose of 28.4 kGy.
- Mar 18, 2015 · Class II · Z-1449-2015: Based on investigation of two complaint incidents, all Hansen Medical Magellan Robotic System (Model No. 11132 and 11139) may experience an unexpected event during a retraction operation of catheter. 

## Indications for use
The Hansen Medical Vascular Catheter Control System, Hansen Catheter and accessory components are intended to be used to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices.

Source page: https://510kreport.com/device/K111004
Methodology: https://510kreport.com/methodology