510(k) K141614

MAGELLAN ROBOTIC SYSTEM by Hansen Medical — Product Code DXX

K141614 is an FDA 510(k) premarket notification submitted by Hansen Medical for the device "MAGELLAN ROBOTIC SYSTEM". The FDA issued a decision of Substantially Equivalent on August 7, 2014. The device falls under product code DXX (System, Catheter Control, Steerable), a Class II device regulated under 21 CFR 870.1290. Hansen Medical has at least 10 other 510(k) clearances on record.