510(k) K201395

Sterile High-pressure Angiographic Syringes for single-use by Youwo (Guangzhou) Medical Device Co., Ltd. — Product Code DXT

K201395 is an FDA 510(k) premarket notification submitted by Youwo (Guangzhou) Medical Device Co., Ltd. for the device "Sterile High-pressure Angiographic Syringes for single-use". The FDA issued a decision of Substantially Equivalent on October 28, 2020. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650.