510(k) K060904

CLEANER ROTATIONAL THROMBECTOMY SYSTEM by Rex Medical, L.P. — Product Code MCW

K060904 is an FDA 510(k) premarket notification submitted by Rex Medical, L.P. for the device "CLEANER ROTATIONAL THROMBECTOMY SYSTEM". The FDA issued a decision of Substantially Equivalent on April 28, 2006. 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.