510(k) K212019

Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Collection Set with Holder for Single Use, Safety Blood Collection Set for Single Use & Blood Collection Set with Holder for Single by Jiangsu Micsafe Medical Technology Co., Ltd. — Product Code JKA

K212019 is an FDA 510(k) premarket notification submitted by Jiangsu Micsafe Medical Technology Co., Ltd. for the device "Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Collection Set with Holder for Single Use, Safety Blood Collection Set for Single Use & Blood Collection Set with Holder for Single". The FDA issued a decision of Substantially Equivalent on November 4, 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. Jiangsu Micsafe Medical Technology Co., Ltd. has at least 4 other 510(k) clearances on record.