INTRASTENT LD (LARGE DIAMETER) STENT

INTRASTENT LD (LARGE DIAMETER) STENT is an FDA 510(k)-cleared medical device (K020528) manufactured by Sulzer 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 15, 2002. Regulation: 8.