OTW MEGALINK SDS BILIARY STENT SYSTEM

OTW MEGALINK SDS BILIARY STENT SYSTEM is an FDA 510(k)-cleared medical device (K000550) manufactured by Advanced Cardiovascular Systems, 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 March 16, 2000. Regulation: 8.