510(k) Report

Devices descending from K050111

5 later devices reach Smarxt BMR 1900 Closed Venous Reservoir Bag through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112771BMR1900 PH.I.S.I.O Venous Reservoir BagSorin Group Italia S.R.L.20112—
+1K070605Jostra Venous Softbag Reservoirs with and Without Safeline CoatingMaquet Cardiopulmonary, AG20081—
+2K223361BMR 1900 PhisioSorin Group Italia S.R.L.20230—
+2K161733Inspire SVR 1200, Inspire 6F C, Inspire 8F CSorin Group Italia S.R.L.20170—
+2K090690Venous Softbag Reservoirs with Softline CoatingMaquet Cardiopulmonary, AG20090—