510(k) K053129

NEXUSTKO NEEDLELESS ACCESS DEVICE, MODEL NIS-5 by Nexus Medical, LLC — Product Code FPA

K053129 is an FDA 510(k) premarket notification submitted by Nexus Medical, LLC for the device "NEXUSTKO NEEDLELESS ACCESS DEVICE, MODEL NIS-5". The FDA issued a decision of Substantially Equivalent on December 8, 2005. 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.