510(k) K163699

ALN Optional Vena Cava Filter - Femoral Approach, ALN Optional Vena Cava Filter - Jugular Approach, ALN Optional Vena Cava Filter - Brachial Approach, ALN Optional Vena Cava Filter - Femoral Approach with Hook by Aln Implants Chirurgicaux — Product Code DTK

K163699 is an FDA 510(k) premarket notification submitted by Aln Implants Chirurgicaux for the device "ALN Optional Vena Cava Filter - Femoral Approach, ALN Optional Vena Cava Filter - Jugular Approach, ALN Optional Vena Cava Filter - Brachial Approach, ALN Optional Vena Cava Filter - Femoral Approach with Hook". The FDA issued a decision of Substantially Equivalent on September 8, 2017. The device falls under product code DTK (Filter, Intravascular, Cardiovascular), a Class II device regulated under 21 CFR 870.3375. Aln Implants Chirurgicaux has at least 2 other 510(k) clearances on record.