510(k) Report

Devices descending from K191585

2 later devices reach iNtuition-Structural Heart Module through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250337AiORTA - PlanViTAA Medical Solutions, Inc.20251—
+2K254207AiORTA - Plan v2.0ViTAA Medical Solutions, Inc.20260—