VAN-TEC DOUBLE OCCLUSION BALLOON CATHETER

VAN-TEC DOUBLE OCCLUSION BALLOON CATHETER is an FDA 510(k)-cleared medical device (K874112) manufactured by Van-Tec, 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 February 10, 1988. Regulation: 8.