510(k) Report

Devices descending from K122926

2 later devices reach Sureflex Steerable Guiding Sheath Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232037Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding SheathInnovative Health, LLC20240—
+1K190688VersaCross Steerable Sheath, VersaCross Transseptal DilatorBaylis Medical Company, Inc.20191—