510(k) K200439

Velano ExT Extension Set by Velano Vascular — Product Code FPA

K200439 is an FDA 510(k) premarket notification submitted by Velano Vascular for the device "Velano ExT Extension Set". The FDA issued a decision of Substantially Equivalent on February 23, 2021. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Velano Vascular has at least 7 other 510(k) clearances on record.