SKATER BILIARY CATHETER

SKATER BILIARY CATHETER is an FDA 510(k)-cleared medical device (K070610) manufactured by Angiotech. 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 20, 2007. Regulation: 8.