510(k) K153388

IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood Collection Set Pre-attached Holder, IMPROSAFE Blood Collection Set, IMPROVACUTER Blood Collection Set, IMPROSAFE Multi Sample Needle, IMPROSAFE Multi Sample Needle (Flashback), IMPROVACUTER Multi Sample Needle by Guangzhou Improve Medical Instruments Co., Ltd. — Product Code FMI

K153388 is an FDA 510(k) premarket notification submitted by Guangzhou Improve Medical Instruments Co., Ltd. for the device "IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood Collection Set Pre-attached Holder, IMPROSAFE Blood Collection Set, IMPROVACUTER Blood Collection Set, IMPROSAFE Multi Sample Needle, IMPROSAFE Multi Sample Needle (Flashback), IMPROVACUTER Multi Sample Needle". The FDA issued a decision of Substantially Equivalent on June 7, 2016. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Guangzhou Improve Medical Instruments Co., Ltd. has at least 1 other 510(k) clearance on record.