510(k) K201237

Velano Vascular Blood Collection Adapter by Velano Vascular — Product Code JKA

K201237 is an FDA 510(k) premarket notification submitted by Velano Vascular for the device "Velano Vascular Blood Collection Adapter". The FDA issued a decision of Substantially Equivalent on October 3, 2022. 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.