510(k) K091140

EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IO by Vidacare Corporation — Product Code FMI

K091140 is an FDA 510(k) premarket notification submitted by Vidacare Corporation for the device "EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IO". The FDA issued a decision of Substantially Equivalent on October 14, 2009. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Vidacare Corporation has at least 10 other 510(k) clearances on record.