510(k) K113398

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

K113398 is an FDA 510(k) premarket notification submitted by Nexus Medical, LLC for the device "NEXUS TKO-6, LUER-ACTIVATED DEVICE". The FDA issued a decision of Substantially Equivalent on April 18, 2012. 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.