510(k) K030504

AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL 10060060 by Idev Technologies, Inc. — Product Code MCW

K030504 is an FDA 510(k) premarket notification submitted by Idev Technologies, Inc. for the device "AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL 10060060". The FDA issued a decision of Substantially Equivalent on September 16, 2003. The device falls under product code MCW (Catheter, Peripheral, Atherectomy), a Class II device regulated under 21 CFR 870.4875. Idev Technologies, Inc. has at least 10 other 510(k) clearances on record.