510(k) K151730

Magellan Robotic System by Hansen Medical, Inc. — Product Code DXX

K151730 is an FDA 510(k) premarket notification submitted by Hansen Medical, Inc. for the device "Magellan Robotic System". The FDA issued a decision of Substantially Equivalent on July 23, 2015. The device falls under product code DXX (System, Catheter Control, Steerable), a Class II device regulated under 21 CFR 870.1290. Hansen Medical, Inc. has at least 10 other 510(k) clearances on record.