510(k) K231849

MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483 by Baxter Healthcare — Product Code KDJ

K231849 is an FDA 510(k) premarket notification submitted by Baxter Healthcare for the device "MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483". The FDA issued a decision of Substantially Equivalent on March 12, 2024. 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.