510(k) K140047

LEXICONTURE MECHANICAL DILATOR SHEATH SET by Spectranetics Corp. — Product Code DRE

K140047 is an FDA 510(k) premarket notification submitted by Spectranetics Corp. for the device "LEXICONTURE MECHANICAL DILATOR SHEATH SET". The FDA issued a decision of Substantially Equivalent on April 9, 2014. The device falls under product code DRE (Dilator, Vessel, For Percutaneous Catheterization), a Class II device regulated under 21 CFR 870.1310. Spectranetics Corp. has at least 10 other 510(k) clearances on record.