FASTRAC GASTRIC ACCESS PORT KIT

FASTRAC GASTRIC ACCESS PORT KIT is an FDA 510(k)-cleared medical device (K033562) manufactured by C.R. Bard, Inc.. 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 December 11, 2003. Regulation: 8.