VDRIVE WITH V-LOOP/ VDRIVE DUO

VDRIVE WITH V-LOOP/ VDRIVE DUO is an FDA 510(k)-cleared medical device (K140804) 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 September 2, 2014. Regulation: 8.