AMSURE 100% SILICONE FOLEY CATHETER

AMSURE 100% SILICONE FOLEY CATHETER is an FDA 510(k)-cleared medical device (K051059) 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 June 27, 2005. Regulation: 8.