510(k) Report

Devices descending from K220305

2 later devices reach Syntheon LAA Exclusion System, Syntheon LAA Selection Guide through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232295LAA Exclusion SystemSyntheon, LLC20231—
+2K252917ATLAAS (Atraumatic Left Atrial Appendage System) (AD)Genesee Biomedical, Inc.20260—