510(k) K031676

HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q by Baxter Healthcare Corp — Product Code KDJ

K031676 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q". The FDA issued a decision of Substantially Equivalent on November 20, 2003. 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 at least 10 other 510(k) clearances on record.