ENDOVATIONS TRIPLE LUMEN BALLOON DILATATION CATHETER

ENDOVATIONS TRIPLE LUMEN BALLOON DILATATION CATHETER is an FDA 510(k)-cleared medical device (K955413) manufactured by Endovations. 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 February 7, 1996. Regulation: 8.