# K151463: Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components

- Pathway: 510(k) (Special)
- Applicant: Hansen Medical, Inc.
- Decided: Aug 18, 2015 after 78 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: 11 generations back to K900765 (1990). 17 ancestors in all.
1 later device descends 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)
- K133552: Magellan Robotic Catheter 6FR (Guide and Leader), Magellan Robotic Catheter 6FR Accessory Kit, Hansen Medical (2014) Summary page 4.

## Most influential descendants
- 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/K151463
Methodology: https://510kreport.com/methodology