EverCrossTM 0.035 OTW PTA Dilatation Catheter

EverCrossTM 0.035 OTW PTA Dilatation Catheter is an FDA 510(k)-cleared medical device (K190753) manufactured by Medtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, 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 April 22, 2019. Regulation: 8.