510(k) K221069

Infusion Sets for Single Use with Needles by Sichuan Prius Biotechnology Co., Ltd. — Product Code FPA

K221069 is an FDA 510(k) premarket notification submitted by Sichuan Prius Biotechnology Co., Ltd. for the device "Infusion Sets for Single Use with Needles". The FDA issued a decision of Substantially Equivalent on November 21, 2022. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Sichuan Prius Biotechnology Co., Ltd. has at least 8 other 510(k) clearances on record.