510(k) K133243

OPTION ELITE VENA CAVA FILTER SYSTEM by Rex Medical, L.P. — Product Code DTK

K133243 is an FDA 510(k) premarket notification submitted by Rex Medical, L.P. for the device "OPTION ELITE VENA CAVA FILTER SYSTEM". The FDA issued a decision of Substantially Equivalent on December 17, 2013. 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.