510(k) Report

Devices descending from K193474

2 later devices reach Selectra 3D Outer Guiding Catheters through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222037Selectra Lead Implantation SystemBiotronik, Inc.20221—
+2K240787Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool…Biotronik, Inc.20240—