COOK URETERAL BALLOON DILATION CATHETER SET

COOK URETERAL BALLOON DILATION CATHETER SET is an FDA 510(k)-cleared medical device (K040127) manufactured by Cook Urological, 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 April 5, 2004. Regulation: 8.