WALLFLEX BILIARY RX PARTIALLY-COVERED STENT SYSTEM

WALLFLEX BILIARY RX PARTIALLY-COVERED STENT SYSTEM is an FDA 510(k)-cleared medical device (K083374) manufactured by Boston Scientific Corp. 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 21, 2009. Regulation: 8.