510(k) K180395

EZ-IO Intraosseous Vascular Access System by Arrow International, Inc. (Subsidiary of Teleflex, Inc.) — Product Code FMI

K180395 is an FDA 510(k) premarket notification submitted by Arrow International, Inc. (Subsidiary of Teleflex, Inc.) for the device "EZ-IO Intraosseous Vascular Access System". The FDA issued a decision of Substantially Equivalent on November 9, 2018. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Arrow International, Inc. (Subsidiary of Teleflex, Inc.) has at least 7 other 510(k) clearances on record.