INTRASTENT DOUBLESTRUT PARAMOUNT BILIARY ENDOPROSTHESIS

INTRASTENT DOUBLESTRUT PARAMOUNT BILIARY ENDOPROSTHESIS is an FDA 510(k)-cleared medical device (K003450) manufactured by Intratherapeutics, 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 December 6, 2000. Regulation: 8.