# K153304: Hansen Medical Magellan Robotic Catheter eKit

- Pathway: 510(k) (Traditional)
- Applicant: Hansen Medical, Inc.
- Decided: Feb 1, 2016 after 77 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: 12 generations back to K900765 (1990). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151463: Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components, Hansen Medical, Inc. (2015) Summary page 4.

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

Source page: https://510kreport.com/device/K153304
Methodology: https://510kreport.com/methodology