510(k) K211518

2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System by Volcano Atheromed, Inc. — Product Code MCW

K211518 is an FDA 510(k) premarket notification submitted by Volcano Atheromed, Inc. for the device "2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System". The FDA issued a decision of Substantially Equivalent on June 14, 2021. The device falls under product code MCW (Catheter, Peripheral, Atherectomy), a Class II device regulated under 21 CFR 870.4875. Volcano Atheromed, Inc. has at least 6 other 510(k) clearances on record.