510(k) K250385

Turbo-Elite Laser Atherectomy Catheter by Spectranetics — Product Code MCW

K250385 is an FDA 510(k) premarket notification submitted by Spectranetics for the device "Turbo-Elite Laser Atherectomy Catheter". The FDA issued a decision of Substantially Equivalent on March 13, 2025. The device falls under product code MCW (Catheter, Peripheral, Atherectomy), a Class II device regulated under 21 CFR 870.4875. Spectranetics has at least 10 other 510(k) clearances on record.