510(k) K180588

FAST1™ Intraosseous Infusion System; FASTResponder™ Sternal Intraosseous Device by Teleflex Medical — Product Code FMI

K180588 is an FDA 510(k) premarket notification submitted by Teleflex Medical for the device "FAST1™ Intraosseous Infusion System; FASTResponder™ Sternal Intraosseous Device". The FDA issued a decision of Substantially Equivalent on April 17, 2018. 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.