510(k) K191419

Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire by Rex Medical, L.P. — Product Code MCW

K191419 is an FDA 510(k) premarket notification submitted by Rex Medical, L.P. for the device "Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire". The FDA issued a decision of Substantially Equivalent on September 12, 2019. The device falls under product code MCW (Catheter, Peripheral, Atherectomy), a Class II device regulated under 21 CFR 870.4875. Rex Medical, L.P. has at least 7 other 510(k) clearances on record.