510(k) K180694

Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters by Spectranetics, Inc. — Product Code MCW

K180694 is an FDA 510(k) premarket notification submitted by Spectranetics, Inc. for the device "Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters". The FDA issued a decision of Substantially Equivalent on April 5, 2018. The device falls under product code MCW (Catheter, Peripheral, Atherectomy), a Class II device regulated under 21 CFR 870.4875. Spectranetics, Inc. has at least 10 other 510(k) clearances on record.