510(k) K152819

Amecath Peripheral inserted Central Venous Catheter Sets by Ameco Medical Industries — Product Code LJS

K152819 is an FDA 510(k) premarket notification submitted by Ameco Medical Industries for the device "Amecath Peripheral inserted Central Venous Catheter Sets". The FDA issued a decision of Substantially Equivalent on February 5, 2016. The device falls under product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days), a Class II device regulated under 21 CFR 880.5970. Ameco Medical Industries has at least 5 other 510(k) clearances on record.