510(k) K213089

Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector by Ivenix, Inc. — Product Code FPA

K213089 is an FDA 510(k) premarket notification submitted by Ivenix, Inc. for the device "Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector". The FDA issued a decision of Substantially Equivalent on November 10, 2021. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Ivenix, Inc. has at least 1 other 510(k) clearance on record.