ATRICURE ISOLATOR TRANSPOLAR PEN

ATRICURE ISOLATOR TRANSPOLAR PEN is an FDA 510(k)-cleared medical device (K050459) manufactured by AtriCure, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 12, 2005. Regulation: 8.