510(k) Report

Devices descending from K101776

15 later devices reach Scoutpro Acs through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120158Coronary Sinus Guide and Lateral Vein Introducer KitsThomas Medical Products, Inc.201232
+1K111839Selectra Accessory KitBiotronik, Inc.20117—
+1K110461Selectra CS Lead Introducer SystemBiotronik, Inc.20118—
+2K1521165.5 F Worley Advanced LVI Lateral Vein IntroducerMerit Medical Systems, Inc.20151—
+2K133501Leadliner CS Lead Delivery SystemVascular Solutions, Inc.20140—
+2K131978Selectra Accessory Kit, Selectra Slitter ToolBiotronik, Inc.20136—
+2K123324Selectra 7F CathetersBiotronik, Inc.20136—
+2K111154Selectra IC-50-60, Selectra IC-50-75, Selectra IC-90-65, Selectra IC-90-75Biotronik, Inc.20116—
+3K260459VANES Delivery System (VDS)Zoll Respicardia, Inc.20260—
+3K183265Selectra Catheters, Selectra Accessory KitBiotronik, Inc.20184—
+3K151409Selectra Catheters and Selectra Accessory KitBiotronik, Inc.20155—
+4K192996Selectra Catheters, Selectra Accessory Kit, Selectra Slitter ToolBiotronik, Inc.20193—
+5K222037Selectra Lead Implantation SystemBiotronik, Inc.20221—
+5K193474Selectra 3D Outer Guiding CathetersBiotronik, Inc.20202—
+6K240787Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool…Biotronik, Inc.20240—