PARAMOUNT MINI STENT AND DELIVERY SYSTEM BILIARY INDICATION

PARAMOUNT MINI STENT AND DELIVERY SYSTEM BILIARY INDICATION is an FDA 510(k)-cleared medical device (K032206) manufactured by Ev3, 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 August 7, 2003. Regulation: 8.