510(k) Report

Devices descending from K991683

103 later devices reach Ptfe Ringed Gore-Tex Vascular Graft through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K220305Syntheon LAA Exclusion System, Syntheon LAA Selection GuideSyntheon20222—
+11K252917ATLAAS (Atraumatic Left Atrial Appendage System) (AD)Genesee Biomedical, Inc.20260—
+11K232295LAA Exclusion SystemSyntheon, LLC20231—