510(k) K211564

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

K211564 is an FDA 510(k) premarket notification submitted by Shenzhen Boon Medical Supply Co., Ltd. for the device "Sterile High-pressure Angiographic Syringes for Single-use". The FDA issued a decision of Substantially Equivalent on October 19, 2021. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. Shenzhen Boon Medical Supply Co., Ltd. has at least 2 other 510(k) clearances on record.