510(k) K214016

15L Cycler Drainage Bag by Baxter Healthcare Corporation — Product Code KDJ

K214016 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corporation for the device "15L Cycler Drainage Bag". The FDA issued a decision of Substantially Equivalent on March 18, 2022. The device falls under product code KDJ (Set, Administration, For Peritoneal Dialysis, Disposable), a Class II device regulated under 21 CFR 876.5630. Baxter Healthcare Corporation has at least 10 other 510(k) clearances on record.