510(k) K072301

5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05 by Ev3, Inc. — Product Code FGE

K072301 is an FDA 510(k) premarket notification submitted by Ev3, Inc. for the device "5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05". The FDA issued a decision of SESU on March 18, 2008. 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. Ev3, Inc. has at least 10 other 510(k) clearances on record.