510(k) K210381

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

K210381 is an FDA 510(k) premarket notification submitted by Bq Plus Medical Co., Ltd. for the device "I.V. Administration Set". The FDA issued a decision of Substantially Equivalent on August 14, 2021. 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.