510(k) K223175

lntravascular Administration Sets with Stopcock and Manifold by Baxter Healthcare Corporation — Product Code FMG

K223175 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corporation for the device "lntravascular Administration Sets with Stopcock and Manifold". The FDA issued a decision of Substantially Equivalent on March 10, 2023. The device falls under product code FMG (Stopcock, I.V. Set), a Class II device regulated under 21 CFR 880.5440. Baxter Healthcare Corporation has at least 10 other 510(k) clearances on record.