510(k) K163508

PIVO by Velano Vascular — Product Code JKA

K163508 is an FDA 510(k) premarket notification submitted by Velano Vascular for the device "PIVO". The FDA issued a decision of Substantially Equivalent on February 9, 2017. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Velano Vascular has at least 7 other 510(k) clearances on record.