510(k) K130416

NEXUS TKO-6P LUER ACTIVATED DEVICE by Nexus Medical, LLC — Product Code FPA

K130416 is an FDA 510(k) premarket notification submitted by Nexus Medical, LLC for the device "NEXUS TKO-6P LUER ACTIVATED DEVICE". The FDA issued a decision of Substantially Equivalent on June 12, 2013. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Nexus Medical, LLC has at least 10 other 510(k) clearances on record.