510(k) K242612

Option ELITE Vena Cava Filter System (352506070E 352506100E) by Argon Medical Devices, Inc. — Product Code DTK

K242612 is an FDA 510(k) premarket notification submitted by Argon Medical Devices, Inc. for the device "Option ELITE Vena Cava Filter System (352506070E 352506100E)". The FDA issued a decision of Substantially Equivalent on September 10, 2024. The device falls under product code DTK (Filter, Intravascular, Cardiovascular), a Class II device regulated under 21 CFR 870.3375. Argon Medical Devices, Inc. has at least 10 other 510(k) clearances on record.