510(k) K012988

HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469 by Baxter Healthcare Corp — Product Code FKX

K012988 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469". The FDA issued a decision of Substantially Equivalent on December 5, 2001. The device falls under product code FKX (System, Peritoneal, Automatic Delivery), a Class II device regulated under 21 CFR 876.5630. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.