510(k) K182289

Sterile High-pressure Angiographic Syringes for Single-use by Shenzhen Baoan Medical Supplies Co., Ltd. — Product Code DXT

K182289 is an FDA 510(k) premarket notification submitted by Shenzhen Baoan Medical Supplies Co., Ltd. for the device "Sterile High-pressure Angiographic Syringes for Single-use". The FDA issued a decision of Substantially Equivalent on Oct 10, 2018. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. Shenzhen Baoan Medical Supplies Co., Ltd. has 1 other 510(k) clearance on record.