510(k) Report

Devices descending from K800122

6 later devices reach Hancock Aortic Punch through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K980128Baladi Inverter with Coaxial Aortic PunchCardio Medical Solutions, Inc.19985—
+2K022880Guidant Proximal Seal System, Models PSS-4500 & PS-4500Guidant Corp.200241
+3K080169Heartstring Iii Proximal Seal SystemGuidant Corporation, Cardiac Surgery20083—
+4K130382Heartstring Iii Proximal Seal SystemBoston Scientific Corporation201323
+5K203307VIOLAVascular Graft Solutions, Ltd.20211—
+6K230248VIOLAVascular Graft Solutions, Ltd.20230—