WallFlex Biliary RX Fully Covered Stent System RMV

WallFlex Biliary RX Fully Covered Stent System RMV is an FDA 510(k)-cleared medical device (DEN150040) manufactured by Boston Scientific. 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 June 2, 2016. Regulation: 8.