510(k) K172386

1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System by Volcano Atheromed, Inc. — Product Code MCW

K172386 is an FDA 510(k) premarket notification submitted by Volcano Atheromed, Inc. for the device "1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System". The FDA issued a decision of Substantially Equivalent on Aug 24, 2017. The device falls under product code MCW (Catheter, Peripheral, Atherectomy), a Class II device regulated under 21 CFR 870.4875. Volcano Atheromed, Inc. has 6 other 510(k) clearances on record.