510(k) K202492

EZ-IO Intraosseous Vascular Access System by Teleflex Medical — Product Code FMI

K202492 is an FDA 510(k) premarket notification submitted by Teleflex Medical for the device "EZ-IO Intraosseous Vascular Access System". The FDA issued a decision of Substantially Equivalent on March 22, 2021. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Teleflex Medical has at least 10 other 510(k) clearances on record.