510(k) K200027

Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter by Jiangsu Caina Medical Co.,Ltd — Product Code JKA

K200027 is an FDA 510(k) premarket notification submitted by Jiangsu Caina Medical Co.,Ltd for the device "Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter". The FDA issued a decision of Substantially Equivalent on September 9, 2020. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Jiangsu Caina Medical Co.,Ltd has at least 10 other 510(k) clearances on record.