AMSURE HYDROPHILIC LATEX FOLEY CATHETER

AMSURE HYDROPHILIC LATEX FOLEY CATHETER is an FDA 510(k)-cleared medical device (K091699) manufactured by Amsino International, 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 August 9, 2009. Regulation: 8.