WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM

WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM is an FDA 510(k)-cleared medical device (K073266) manufactured by Boston Scientific Corp. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 26, 2008. Regulation: 8.