510(k) K211035

U9000 Plus Ultrafilter by Baxter Healthcare Corporation — Product Code FIP

K211035 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corporation for the device "U9000 Plus Ultrafilter". The FDA issued a decision of Substantially Equivalent on October 19, 2021. The device falls under product code FIP (Subsystem, Water Purification), a Class II device regulated under 21 CFR 876.5665. Baxter Healthcare Corporation has at least 10 other 510(k) clearances on record.