510(k) K034050

CORDIS OPTEASE VENA CAVA FILTER, MODELS 466-F220A AND 466-F220B; RETRIEVABLE CATHETER, MODEL 466-C220F by Cordis Corporation — Product Code DTK

K034050 is an FDA 510(k) premarket notification submitted by Cordis Corporation for the device "CORDIS OPTEASE VENA CAVA FILTER, MODELS 466-F220A AND 466-F220B; RETRIEVABLE CATHETER, MODEL 466-C220F". The FDA issued a decision of Substantially Equivalent on March 22, 2004. The device falls under product code DTK (Filter, Intravascular, Cardiovascular), a Class II device regulated under 21 CFR 870.3375. Cordis Corporation has at least 10 other 510(k) clearances on record.