510(k) K152129

FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution by Baxter Healthcare Corporation — Product Code KDJ

K152129 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corporation for the device "FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution". The FDA issued a decision of Substantially Equivalent on October 29, 2015. 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 Corporation has at least 10 other 510(k) clearances on record.