510(k) K141530

VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS by Stereotaxis, Inc. — Product Code DXX

K141530 is an FDA 510(k) premarket notification submitted by Stereotaxis, Inc. for the device "VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS". The FDA issued a decision of Substantially Equivalent on December 18, 2014. The device falls under product code DXX (System, Catheter Control, Steerable), a Class II device regulated under 21 CFR 870.1290. Stereotaxis, Inc. has at least 10 other 510(k) clearances on record.