510(k) K092527

NEXUS INJECTION SITE, MODEL NIS-8 by Nexus Medical, LLC — Product Code FPA

K092527 is an FDA 510(k) premarket notification submitted by Nexus Medical, LLC for the device "NEXUS INJECTION SITE, MODEL NIS-8". The FDA issued a decision of Substantially Equivalent on February 4, 2010. 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.