510(k) K043490

PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE by Vidacare Corporation — Product Code FMI

K043490 is an FDA 510(k) premarket notification submitted by Vidacare Corporation for the device "PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE". The FDA issued a decision of Substantially Equivalent on February 18, 2005. 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.