510(k) Report

Devices descending from K130382

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203307VIOLAVascular Graft Solutions, Ltd.20211—
+2K230248VIOLAVascular Graft Solutions, Ltd.20230—