510(k) K043401

SPECTRANETICS LLD CS, MODEL 518-039 by Spectranetics Corp. — Product Code DRB

K043401 is an FDA 510(k) premarket notification submitted by Spectranetics Corp. for the device "SPECTRANETICS LLD CS, MODEL 518-039". The FDA issued a decision of Substantially Equivalent on March 16, 2005. The device falls under product code DRB (Stylet, Catheter), a Class II device regulated under 21 CFR 870.1380. Spectranetics Corp. has at least 10 other 510(k) clearances on record.