NC TREK RX CORONARY DILATATION CATHETER

NC TREK RX CORONARY DILATATION CATHETER is an FDA 510(k)-cleared medical device (K110134) manufactured by Abbott Vascular-Cardiac Therapies. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 10, 2011. Regulation: 8.