510(k) K202437

Infusion Sets for Single Use by Jiangsu Suyun Medical Materials Co., Ltd. — Product Code FPA

K202437 is an FDA 510(k) premarket notification submitted by Jiangsu Suyun Medical Materials Co., Ltd. for the device "Infusion Sets for Single Use". The FDA issued a decision of Substantially Equivalent on March 25, 2022. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Jiangsu Suyun Medical Materials Co., Ltd. has at least 1 other 510(k) clearance on record.