TAUT BALLOON CATHETER, MODEL 50640

TAUT BALLOON CATHETER, MODEL 50640 is an FDA 510(k)-cleared medical device (K011018) manufactured by Taut, 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 21, 2001. Regulation: 8.