510(k) Report

Devices descending from K821717

4 later devices reach Gore-Tes Expanded Ptfe Patch through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K962342Hemashield Finesse Ultra-Thin, Knitted Cardiovascular PatchMeadox Medicals, Div. Boston Scientific Corp.199632
+2K112683Smi Cardiovascular PachSolimas Medical, Inc.20111—
+2K101740Albosure Polyester Vascular PatchLeMaitre Vascular, Inc.20100—
+3K122105Smi Cardiovascular PatchSolinas Medical, Inc.20120—