LiteSaber Wire Torque Assist Device

LiteSaber Wire Torque Assist Device is an FDA 510(k)-cleared medical device (K200120) manufactured by Vesatek, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 6, 2020. Regulation: 8.