
Boston Scientific
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WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV is an FDA 510(k)-cleared medical device (K240464) 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 August 29, 2024. Regulation: 8.