510(k) Report

Devices descending from K982650

8 later devices reach Autologous Blood Management System (Abms) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103202Preassembled Surgical Wash SetSorin Group Italia S.R.L.20100—
+1K060482Cytori Celution Cell Concentration DeviceCytori Therapeutics, Inc.20060—
+1K020647Dideco ElectaDideco S.P.A.200272
+2K101586Xtra Autotransfusion SystemSorin Group Italia S.R.L.20105—
+3K241236XTRA Collection sets; XTRA Sequestration set XSorin Group Italia S.R.L.20240—
+3K240584XTRA Autotransfusion System (with XTRA Bowl sets)Sorin Group Italia S.R.L.20240—
+3K112245XTRASorin Group Italia S.R.L.20111—
+4K131553XTRASorin Group Deutschland GmbH20140—