510(k) Report

Devices descending from K050459

18 later devices reach Atricure Isolator Transpolar Pen through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100501Multifunctional Linear PenAtriCure, Inc.20109—
+1K073605Atricure Coolrail Linear PenAtriCure, Inc.200813—
+1K061593Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1AtriCure, Inc.2006131
+2K192125Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear PenAtriCure, Inc.20191—
+2K130521Isolator Linear PenAtriCure, Inc.20133—
+2K122611Coolrail Linear Pen Model McriAtriCure, Inc.20123—
+2K113475Estech Cobra Adhere XL 2 Surgical SystemEndoscopic Technologies, Inc. D/B/A Estech201245
+2K070288Cardioblate Monopolar Pen, 60813, Cardioblate Monopolar XL, 60814Medtronic Vascular20072—
+3K221358Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear…AtriCure, Inc.20220—
+3K190151COBRA Fusion Ablation SystemAtriCure, Inc.20190—
+3K183065Coolrail Linear PenAtriCure, Inc.20182—
+3K163408Isolator Multifunctional Linear PenAtriCure, Inc.20172—
+3K120857Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc.20122—
+3K090721Cardioblate Maps Surgical Mapping, Ablation, Pacing and Sensing Device, Model 49205Medtronic20091—
+4K190587Coolrail Linear PenAtriCure, Inc.20191—
+4K142084Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc.201411
+4K121451Cardioblate Maps Surgical Mapping, Ablation, Pacing , and Sensing DeviceMedtronic, Inc.20120—
+5K193162EPi-Sense Guided Coagulation System with VisiTraxAtriCure, Inc.20190—