510(k) Report

Devices descending from K190688

1 later device reach VersaCross Steerable Sheath, VersaCross Transseptal Dilator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232037Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding SheathInnovative Health, LLC20240—