510(k) K242339

Intravascular Extension Sets and Accessories by Baxter Healthcare Corporation — Product Code FPA

K242339 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corporation for the device "Intravascular Extension Sets and Accessories". The FDA issued a decision of Substantially Equivalent on February 28, 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.