510(k) K032885

VIDAPORT INTRAOSSEOUS INFUSION SYSTEM by Vidacare Corporation — Product Code FMI

K032885 is an FDA 510(k) premarket notification submitted by Vidacare Corporation for the device "VIDAPORT INTRAOSSEOUS INFUSION SYSTEM". The FDA issued a decision of Substantially Equivalent on March 10, 2004. 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.