VASCUTRAK 2, MODELS: V14 AND V18

VASCUTRAK 2, MODELS: V14 AND V18 is an FDA 510(k)-cleared medical device (K082343) manufactured by Ymed, 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 10, 2008. Regulation: 8.