510(k) K243529

Solution Administration Sets by Baxter Healthcare Corporation — Product Code FPA

K243529 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corporation for the device "Solution Administration Sets". The FDA issued a decision of Substantially Equivalent on March 14, 2025. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Baxter Healthcare Corporation has at least 10 other 510(k) clearances on record.