510(k) K030201

MODIFICATION TO EXPORT ASPIRATION CATHETER by Medtronic Vascular — Product Code NFA

K030201 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "MODIFICATION TO EXPORT ASPIRATION CATHETER". The FDA issued a decision of Substantially Equivalent on March 26, 2003. The device falls under product code NFA (Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection), a Class II device regulated under 21 CFR 870.1250. Medtronic Vascular has at least 10 other 510(k) clearances on record.