NC TREK NEO Coronary Dilatation Catheter

NC TREK NEO Coronary Dilatation Catheter is an FDA 510(k)-cleared medical device (K220634) manufactured by Abbott Vascular. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 29, 2022. Regulation: 8.