510(k) K091808

SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057 by Hansen Medical, Inc. — Product Code DXX

K091808 is an FDA 510(k) premarket notification submitted by Hansen Medical, Inc. for the device "SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057". The FDA issued a decision of SESU on September 10, 2009. 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.