510(k) K090140

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

K090140 is an FDA 510(k) premarket notification submitted by William Cook Europe Aps for the device "GUNTHER TULIP VENA CAVA FILTER, COOK CELECT VENA CAVA FILTER". The FDA issued a decision of Substantially Equivalent on April 3, 2009. 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.