510(k) K201009

CHIRAVAC Blood Collection Needles by Chirana T. Injecta — Product Code JKA

K201009 is an FDA 510(k) premarket notification submitted by Chirana T. Injecta for the device "CHIRAVAC Blood Collection Needles". The FDA issued a decision of Substantially Equivalent on Jul 21, 2021. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Chirana T. Injecta has at least 3 other 510(k) clearances on record.