AMSURE PVC INTERMITTENT CATHETER

AMSURE PVC INTERMITTENT CATHETER is an FDA 510(k)-cleared medical device (K091306) 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 20, 2009. Regulation: 8.