CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900

CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900 is an FDA 510(k)-cleared medical device (K063061) manufactured by Viasys 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 April 1, 2007. Regulation: 8.