VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS

VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS is an FDA 510(k)-cleared medical device (K141530) manufactured by Stereotaxis, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 17, 2014. Regulation: 8.