510(k) Report

Devices descending from K971265

23 later devices reach Viking Diagnostic Electrode Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250310VIKING™ Fixed Curve Diagnostic CatheterBoston Scientific Corporation20250—
+1K162251Reprocessed Viking Diagnostic Electrophysiology CathetersInnovative Health, LLC20160—
+1K061593Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1AtriCure, Inc.2006131
+1K030627Orbiter PV Diagnostic Electrode Catheter, Models 320100 & 320110C.R. Bard, Inc.20030—
+1K012708Electrophysiology CatheterAlliance Medical Corp.2002529
+2K192125Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear PenAtriCure, Inc.20191—
+2K100501Multifunctional Linear PenAtriCure, Inc.20109—
+2K070288Cardioblate Monopolar Pen, 60813, Cardioblate Monopolar XL, 60814Medtronic Vascular20072—
+2K052414Reprocessed Electrophysiology CatheterAlliance Medical Corp.20050—
+2K052603Reprocessed Daig Livewire Electrophysiology CathetersAlliance Medical Corp.2005026
+2K043392Reprocessed Electrophysiology CathetersAlliance Medical Corp.20050—
+2K043393Reprocessed EP Technologies Electrophysiology CathetersAlliance Medical Corp.20051—
+2K030026Reprocessed Electrophysiology CatheterAlliance Medical Corp.20030—
+3K221358Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear…AtriCure, Inc.20220—
+3K130521Isolator Linear PenAtriCure, Inc.20133—
+3K113475Estech Cobra Adhere XL 2 Surgical SystemEndoscopic Technologies, Inc. D/B/A Estech201245
+3K090721Cardioblate Maps Surgical Mapping, Ablation, Pacing and Sensing Device, Model 49205Medtronic20091—
+4K190151COBRA Fusion Ablation SystemAtriCure, Inc.20190—
+4K163408Isolator Multifunctional Linear PenAtriCure, Inc.20172—
+4K120857Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc.20122—
+4K121451Cardioblate Maps Surgical Mapping, Ablation, Pacing , and Sensing DeviceMedtronic, Inc.20120—
+5K142084Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc.201411
+6K193162EPi-Sense Guided Coagulation System with VisiTraxAtriCure, Inc.20190—