510(k) Report

Devices descending from K980128

5 later devices reach Baladi Inverter with Coaxial Aortic Punch through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K022880Guidant Proximal Seal System, Models PSS-4500 & PS-4500Guidant Corp.200241
+2K080169Heartstring Iii Proximal Seal SystemGuidant Corporation, Cardiac Surgery20083—
+3K130382Heartstring Iii Proximal Seal SystemBoston Scientific Corporation201323
+4K203307VIOLAVascular Graft Solutions, Ltd.20211—
+5K230248VIOLAVascular Graft Solutions, Ltd.20230—