CORTRAK ENTERAL ACCESS DEVICE

CORTRAK ENTERAL ACCESS DEVICE is an FDA 510(k)-cleared medical device (K113351) manufactured by Corpak Medsystems. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 9, 2012. Regulation: 8.