INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS

INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS is an FDA 510(k)-cleared medical device (K003997) 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 January 23, 2001. Regulation: 8.