510(k) K030966

CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER by Boston Scientific Corp — Product Code NAJ

K030966 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER". The FDA issued a decision of Substantially Equivalent on September 23, 2003. The device falls under product code NAJ (Agents, Embolic, For Treatment Of Uterine Fibroids), a Class II device regulated under 21 CFR 870.3300. Boston Scientific Corp has at least 10 other 510(k) clearances on record.