RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2

RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2 is an FDA 510(k)-cleared medical device (K041705) manufactured by Omnisonics Medical Technologies. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 31, 2004. Regulation: 8.