510(k) K143328

1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip by Volcano Atheromed, Inc. — Product Code MCW

K143328 is an FDA 510(k) premarket notification submitted by Volcano Atheromed, Inc. for the device "1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip". The FDA issued a decision of Substantially Equivalent on December 19, 2014. 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.