ELITECROSS Support Catheter

ELITECROSS Support Catheter is an FDA 510(k)-cleared medical device (K150187) manufactured by Cordis Corporation, A Johnson & Johnson Company. 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 18, 2015. Regulation: 8.