510(k) Report

Devices descending from K183655

2 later devices reach VersaCross Transseptal Sheath through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231108Talon Transseptal SheathInari Medical, Inc.20230—
+1K213492Dib UltraNav Transseptal Catheter SystemDib Ultranav Medical, LLC20220—