510(k) Report

Devices descending from K052964

11 later devices reach Exxcel and Exxcel Soft Eptfe Vascular Grafts, Microvel Double Velour Knitted… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131778Fusion Vascular Graft and Fusion Bioline Vascular GraftMaquet Cardiovascular, LLC201321
+1K071778Hero Vascular Access DeviceGraftcath, Inc.20087—
+2K252445Fusion Bioline Vascular GraftMaquet Cardiovascular, LLC20260—
+2K153523FUSION Vascular GraftMaquet Cardiovascular, LLC20160—
+2K124039Hero GraftHemoshpere, Inc., A Cryolife Company20133—
+2K121532Hero GraftHemosphere, Inc.20124—
+2K120006Hero GraftHemosphere, Inc.20125—
+2K091491Hero Vascular Access DeviceHemosphere, Inc.20096—
+3K172637HeRO GraftMerit Medical Systems, Inc.20172—
+4K203724HeRO Graft, HeRO AdapterMerit Medical Systems, Inc.20211—
+5K213845HeRO GraftMerit Medical Systems, Inc.20220—