INTRASTENT DOUBLESTRUT XS STENT

INTRASTENT DOUBLESTRUT XS STENT is an FDA 510(k)-cleared medical device (K000864) 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 April 13, 2000. Regulation: 8.