510(k) K143227

Magellan Robotic System, Magellan Robotic Catheter 10Fr by Hansen Medical, Inc. — Product Code DXX

K143227 is an FDA 510(k) premarket notification submitted by Hansen Medical, Inc. for the device "Magellan Robotic System, Magellan Robotic Catheter 10Fr". The FDA issued a decision of Substantially Equivalent on July 1, 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.