510(k) K073225

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

K073225 is an FDA 510(k) premarket notification submitted by Hansen Medical, Inc. for the device "SENSEI CATHETER CONTROL SYSTEM". The FDA issued a decision of SESU on June 30, 2008. 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.