510(k) Report

Devices descending from K830806

23 later devices reach Vascular Graft/Bifurcated/Fep-Ringed through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062161Gore Propaten Vascular GraftW. L. Gore & Associates, Inc.200672
+1K960766Meadox Medicals, Inc. Expanded Ptfe Vascular GraftMeadox Medicals, Div. Boston Scientific Corp.199712—
+1K955460Meadox Medicals, Inc., Expanded & Externally Supported Expanded Ptfe Vascular GraftMeadox Medicals, Div. Boston Scientific Corp.199613—
+2K232312GORE® PROPATEN® Vascular GraftW. L. Gore & Associates, Inc.20241—
+2K130215Gore Acuseal Vascular GraftW. L. Gore & Associates, Inc.20132—
+2K100984Xylos Vessel GuardXylos Corporation20100—
+2K093934Gore Hybrid Vascular GraftW.L. Gore & Associates20100—
+2K052964Exxcel and Exxcel Soft Eptfe Vascular Grafts, Microvel Double Velour Knitted Vascular…Boston Scientific Corp2006113
+2K962433Meadox Exxcel Eptfe Vascular GraftMeadox Medicals, Div. Boston Scientific Corp.199712—
+3K240083GORE® PROPATEN® Vascular GraftW. L. Gore & Associates, Inc.20240—
+3K231505GORE® ACUSEAL Vascular GraftW. L. Gore & Associates, Inc.20231—
+3K153523FUSION Vascular GraftMaquet Cardiovascular, LLC20160—
+3K131778Fusion Vascular Graft and Fusion Bioline Vascular GraftMaquet Cardiovascular, LLC201321
+3K071778Hero Vascular Access DeviceGraftcath, Inc.20087—
+4K252445Fusion Bioline Vascular GraftMaquet Cardiovascular, LLC20260—
+4K233551GORE® ACUSEAL Vascular GraftW. L. Gore & Associates, Inc.202301
+4K124039Hero GraftHemoshpere, Inc., A Cryolife Company20133—
+4K121532Hero GraftHemosphere, Inc.20124—
+4K120006Hero GraftHemosphere, Inc.20125—
+4K091491Hero Vascular Access DeviceHemosphere, Inc.20096—
+5K172637HeRO GraftMerit Medical Systems, Inc.20172—
+6K203724HeRO Graft, HeRO AdapterMerit Medical Systems, Inc.20211—
+7K213845HeRO GraftMerit Medical Systems, Inc.20220—