510(k) K143405

Option (TM) ELITE Vena Cava Filter 100cm System by Rex Medical, L.P. — Product Code DTK

K143405 is an FDA 510(k) premarket notification submitted by Rex Medical, L.P. for the device "Option (TM) ELITE Vena Cava Filter 100cm System". The FDA issued a decision of Substantially Equivalent on April 16, 2015. The device falls under product code DTK (Filter, Intravascular, Cardiovascular), a Class II device regulated under 21 CFR 870.3375. Rex Medical, L.P. has at least 7 other 510(k) clearances on record.