510(k) K220558

Blood Administration Sets by Baxter Healthcare Corporation — Product Code BRZ

K220558 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corporation for the device "Blood Administration Sets". The FDA issued a decision of Substantially Equivalent on November 17, 2022. The device falls under product code BRZ (Set, Blood Transfusion), a Class II device regulated under 21 CFR 880.5440. Baxter Healthcare Corporation has at least 10 other 510(k) clearances on record.