510(k) K000550

OTW MEGALINK SDS BILIARY STENT SYSTEM by Advanced Cardiovascular Systems, Inc. — Product Code FGE

K000550 is an FDA 510(k) premarket notification submitted by Advanced Cardiovascular Systems, Inc. for the device "OTW MEGALINK SDS BILIARY STENT SYSTEM". The FDA issued a decision of SESU on March 17, 2000. The device falls under product code FGE (Stents, Drains And Dilators For The Biliary Ducts), a Class II device regulated under 21 CFR 876.5010. Advanced Cardiovascular Systems, Inc. has at least 10 other 510(k) clearances on record.