# K133552: Magellan Robotic Catheter 6FR (Guide and Leader), Magellan Robotic Catheter 6FR Accessory Kit

- Pathway: 510(k) (Special)
- Applicant: Hansen Medical
- Decided: Feb 7, 2014 after 80 days
- Product code: DRA (Catheter, Steerable)
- Device class: 2
- Regulation: 21 CFR 870.1280
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K900765 (1990). 16 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132369: Magellan Robotic System, Magellan Robotic Catheter 9FR, Hansen Medical, Inc. (2013) Summary page 4.

## Most influential descendants
- K151463: Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components (2015), 1 descendant of its own
- K153304: Hansen Medical Magellan Robotic Catheter eKit (2016), 0 descendants of its own

## Indications for use
The Hansen Medical Magellan Robotic Catheter 6Fr 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 6Fr is intended to be used with the Hansen Medical Magellan Robotic System and accessories.

Source page: https://510kreport.com/device/K133552
Methodology: https://510kreport.com/methodology