510(k) Report

Devices descending from K033484

3 later devices reach Human Heart Valve, Cryovalve SG through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092021Cryovalve SG Pulmonary Human Heart Valve (and Conduit)Cryolife, Inc.201025
+2K252059CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00)Artivion, Inc.20250—
+2K101866Cryopatch SG Pulmonary Human Cardiac PatchCryolife, Inc.201005