510(k) K110794

AMECATH CVC AND AMECATH PRESSURE CVC SHORT TERM SINGLE AND MULTI-LUMEN CATHERIZATION KITS by Ameco Medical Industries — Product Code FOZ

K110794 is an FDA 510(k) premarket notification submitted by Ameco Medical Industries for the device "AMECATH CVC AND AMECATH PRESSURE CVC SHORT TERM SINGLE AND MULTI-LUMEN CATHERIZATION KITS". The FDA issued a decision of Substantially Equivalent on December 21, 2011. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Ameco Medical Industries has at least 5 other 510(k) clearances on record.