510(k) K141822

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

K141822 is an FDA 510(k) premarket notification submitted by Hanson Medical, Inc. for the device "SENSEI X ROBOTIC CATHETER SYSTEM". The FDA issued a decision of Substantially Equivalent on August 5, 2014. The device falls under product code DXX (System, Catheter Control, Steerable), a Class II device regulated under 21 CFR 870.1290. Hanson Medical, Inc. has at least 10 other 510(k) clearances on record.