510(k) Report

Devices descending from K980786

6 later devices reach Cobe Closed Venous Reservoir Bags with Smarx T, Models VRB 1200 and VRB 1800 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050111Smarxt BMR 1900 Closed Venous Reservoir BagCobe Cardiovascular, Inc.20055—
+2K112771BMR1900 PH.I.S.I.O Venous Reservoir BagSorin Group Italia S.R.L.20112—
+2K070605Jostra Venous Softbag Reservoirs with and Without Safeline CoatingMaquet Cardiopulmonary, AG20081—
+3K223361BMR 1900 PhisioSorin Group Italia S.R.L.20230—
+3K161733Inspire SVR 1200, Inspire 6F C, Inspire 8F CSorin Group Italia S.R.L.20170—
+3K090690Venous Softbag Reservoirs with Softline CoatingMaquet Cardiopulmonary, AG20090—