VAN-TEC GUIDE WIRE W/HYDROMER COATING

VAN-TEC GUIDE WIRE W/HYDROMER COATING is an FDA 510(k)-cleared medical device (K851160) 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 July 28, 1985. Regulation: 8.