510(k) K110793

AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS by Ameco Medical Industries — Product Code MPB

K110793 is an FDA 510(k) premarket notification submitted by Ameco Medical Industries for the device "AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS". The FDA issued a decision of Substantially Equivalent on December 16, 2011. The device falls under product code MPB (Catheter, Hemodialysis, Non-Implanted), a Class II device regulated under 21 CFR 876.5540. Ameco Medical Industries has at least 5 other 510(k) clearances on record.