510(k) Report

Devices descending from K111154

6 later devices reach Selectra IC-50-60, Selectra IC-50-75, Selectra IC-90-65, Selectra IC-90-75 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151409Selectra Catheters and Selectra Accessory KitBiotronik, Inc.20155—
+2K183265Selectra Catheters, Selectra Accessory KitBiotronik, Inc.20184—
+3K192996Selectra Catheters, Selectra Accessory Kit, Selectra Slitter ToolBiotronik, Inc.20193—
+4K222037Selectra Lead Implantation SystemBiotronik, Inc.20221—
+4K193474Selectra 3D Outer Guiding CathetersBiotronik, Inc.20202—
+5K240787Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool…Biotronik, Inc.20240—