510(k) Report

Devices descending from K081313

1 later device reach SH14 Hemoconcentrator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243264DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14…Sorin Group Italia S.R.L.20250—