510(k) K113124

ALN OPTIONAL VANA CAVA FILTER by Aln Implants Chirurgicaux — Product Code DTK

K113124 is an FDA 510(k) premarket notification submitted by Aln Implants Chirurgicaux for the device "ALN OPTIONAL VANA CAVA FILTER". The FDA issued a decision of Substantially Equivalent on November 9, 2012. 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.