510(k) K121057

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

K121057 is an FDA 510(k) premarket notification submitted by William Cook Europe Aps for the device "COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS". The FDA issued a decision of Substantially Equivalent on May 4, 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.