510(k) Report

Devices descending from K962342

3 later devices reach Hemashield Finesse Ultra-Thin, Knitted Cardiovascular Patch through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112683Smi Cardiovascular PachSolimas Medical, Inc.20111—
+1K101740Albosure Polyester Vascular PatchLeMaitre Vascular, Inc.20100—
+2K122105Smi Cardiovascular PatchSolinas Medical, Inc.20120—