# K132369: Magellan Robotic System, Magellan Robotic Catheter 9FR

- Pathway: 510(k) (Special)
- Applicant: Hansen Medical, Inc.
- Decided: Sep 27, 2013 after 59 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: 9 generations back to K900765 (1990). 15 ancestors in all.
9 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)
- K111004: Hansen Medical Vascular Catheter Control System and Catheter, Hansen Medical, Inc. (2012) Summary page 1.

## Most influential descendants
- 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
- K151463: Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components (2015), 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
Magellan Robotic System: The Hansen Medical Magellan Robotic System 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. The Magellan Robotic System is intended to be used with compatible Hansen Medical robotically steerable catheters. Magellan Robotic Catheter 9Fr: The Hansen Medical Magellan Robotic Catheter 9Fr is 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. The Magellan Robotic Catheter 9Fr is intended to be used with the Hansen Medical Magellan Robotic System and accessories.

Source page: https://510kreport.com/device/K132369
Methodology: https://510kreport.com/methodology