510(k) Report

Devices descending from K080169

3 later devices reach Heartstring Iii Proximal Seal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130382Heartstring Iii Proximal Seal SystemBoston Scientific Corporation201323
+2K203307VIOLAVascular Graft Solutions, Ltd.20211—
+3K230248VIOLAVascular Graft Solutions, Ltd.20230—