510(k) K053512

HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310 by Baxter Healthcare Corp — Product Code FKX

K053512 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310". The FDA issued a decision of Substantially Equivalent on February 16, 2006. 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.