510(k) K230080

Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood by Yangzhou Medline Industry, Co., Ltd. — Product Code JKA

K230080 is an FDA 510(k) premarket notification submitted by Yangzhou Medline Industry, Co., Ltd. for the device "Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood". The FDA issued a decision of Substantially Equivalent on July 7, 2023. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Yangzhou Medline Industry, Co., Ltd. has at least 1 other 510(k) clearance on record.