510(k) Report

Devices descending from K193509

3 later devices reach AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210685AcQCross Qx Integrated Transseptal Dilator/NeedleAcutus Medical, Inc.20212—
+2K233691FlexCath Cross Transseptal SolutionAcutus Medical, Inc.20230—
+2K220047AcQCross Qx Integrated Transseptal Dilator/NeedleAcutus Medical, Inc.20220—