510(k) K972579

HIGH DOSE DISCONNECT CAP AND MINICAP WITH POVIDONE-IODINE, HIGH DOSE DISCONNECT CAP WITH POVIDONE-IODINE by Baxter Healthcare Corp — Product Code KDJ

K972579 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "HIGH DOSE DISCONNECT CAP AND MINICAP WITH POVIDONE-IODINE, HIGH DOSE DISCONNECT CAP WITH POVIDONE-IODINE". The FDA issued a decision of Substantially Equivalent on October 1, 1997. 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.