1 OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER

1 OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER is an FDA 510(k)-cleared medical device (K000793) manufactured by Guidant Corp.. 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 11, 2000. Regulation: 8.