510(k) K961825

ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493 by Baxter Healthcare Corp — Product Code KDJ

K961825 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493". The FDA issued a decision of Substantially Equivalent on Aug 6, 1996. 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 Corp has 507 other 510(k) clearances on record.