510(k) K121629

COOK CELECT PLATINUM VENA CAVA FILTER SET FOR FEMORAL APPROACH COOK CELECT PLATIUM VENA CAVA FILTER SET FOR JUGULAR APPR by William Cook Europe Aps — Product Code DTK

K121629 is an FDA 510(k) premarket notification submitted by William Cook Europe Aps for the device "COOK CELECT PLATINUM VENA CAVA FILTER SET FOR FEMORAL APPROACH COOK CELECT PLATIUM VENA CAVA FILTER SET FOR JUGULAR APPR". The FDA issued a decision of Substantially Equivalent on July 3, 2012. 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.