510(k) K223645

I.V. Administration Set, I.V. Extension Set by Bq Plus Medical Co., Ltd. — Product Code FPA

K223645 is an FDA 510(k) premarket notification submitted by Bq Plus Medical Co., Ltd. for the device "I.V. Administration Set, I.V. Extension Set". The FDA issued a decision of Substantially Equivalent on May 18, 2023. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Bq Plus Medical Co., Ltd. has at least 2 other 510(k) clearances on record.