510(k) K243264

DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14) by Sorin Group Italia S.R.L. — Product Code KDI

K243264 is an FDA 510(k) premarket notification submitted by Sorin Group Italia S.R.L. for the device "DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)". The FDA issued a decision of Substantially Equivalent on April 25, 2025. The device falls under product code KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System), a Class II device regulated under 21 CFR 876.5860. Sorin Group Italia S.R.L. has at least 10 other 510(k) clearances on record.