510(k) K102168

SENSEI X ROBOTIC CATHETER SYSTEM by Hansen Medical, Inc. — Product Code DXX

K102168 is an FDA 510(k) premarket notification submitted by Hansen Medical, Inc. for the device "SENSEI X ROBOTIC CATHETER SYSTEM". The FDA issued a decision of Substantially Equivalent on October 22, 2010. 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.