510(k) K252543

AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04) by Amsino International, Inc. — Product Code FPA

K252543 is an FDA 510(k) premarket notification submitted by Amsino International, Inc. for the device "AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)". The FDA issued a decision of Substantially Equivalent on May 4, 2026. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Amsino International, Inc. has at least 10 other 510(k) clearances on record.