# K160919: Hansen Medical Magellan Robotic Catheter 9Fr

- Pathway: 510(k) (Traditional)
- Applicant: Hansen Medical, Inc.
- Decided: Sep 20, 2016 after 169 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: 5 generations back to K010954 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082385: Chaperon Guiding Catheter, MicroVention, Inc. (2008) Summary page 4.

## Indications for use
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 Long Length (80 cm) is also indicated for use as a conduit for manual placement of therapeutic devices in the neuro vasculature. 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/K160919
Methodology: https://510kreport.com/methodology