510(k) K132369

MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR by Hansen Medical, Inc. — Product Code DXX

K132369 is an FDA 510(k) premarket notification submitted by Hansen Medical, Inc. for the device "MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR". The FDA issued a decision of Substantially Equivalent on September 27, 2013. 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.