510(k) Report

Devices descending from K022880

4 later devices reach Guidant Proximal Seal System, Models PSS-4500 & PS-4500 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080169Heartstring Iii Proximal Seal SystemGuidant Corporation, Cardiac Surgery20083—
+2K130382Heartstring Iii Proximal Seal SystemBoston Scientific Corporation201323
+3K203307VIOLAVascular Graft Solutions, Ltd.20211—
+4K230248VIOLAVascular Graft Solutions, Ltd.20230—