510(k) K061815

COOK CELECT VENA CAVA FILTER by William Cook Europe Aps — Product Code DTK

K061815 is an FDA 510(k) premarket notification submitted by William Cook Europe Aps for the device "COOK CELECT VENA CAVA FILTER". The FDA issued a decision of Substantially Equivalent on April 20, 2007. The device falls under product code DTK (Filter, Intravascular, Cardiovascular), a Class II device regulated under 21 CFR 870.3375. William Cook Europe Aps has at least 10 other 510(k) clearances on record.