510(k) K192705

MiniCap Extended Life PD Transfer Sets by Baxter Healthcare — Product Code KDJ

K192705 is an FDA 510(k) premarket notification submitted by Baxter Healthcare for the device "MiniCap Extended Life PD Transfer Sets". The FDA issued a decision of Substantially Equivalent on October 25, 2019. 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 has at least 10 other 510(k) clearances on record.