510(k) Report

Devices descending from K092021

2 later devices reach Cryovalve SG Pulmonary Human Heart Valve (and Conduit) through their predicates, nearest generation first.

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