510(k) Report

Devices descending from K040812

20 later devices reach Detect Surgical Pacing and Mapping Tool through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090721Cardioblate Maps Surgical Mapping, Ablation, Pacing and Sensing Device, Model 49205Medtronic20091—
+1K070288Cardioblate Monopolar Pen, 60813, Cardioblate Monopolar XL, 60814Medtronic Vascular20072—
+1K061593Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1AtriCure, Inc.2006131
+1K051749Cobra Surgical SystemEstech, Inc.200519—
+2K192125Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear PenAtriCure, Inc.20191—
+2K150134Basic, Dominant Flex, KV-6Medela AG20152—
+2K121451Cardioblate Maps Surgical Mapping, Ablation, Pacing , and Sensing DeviceMedtronic, Inc.20120—
+2K113475Estech Cobra Adhere XL 2 Surgical SystemEndoscopic Technologies, Inc. D/B/A Estech201245
+2K110913Estech Cobra Surgical System with Thermashield AccessoryEndoscopic Technologies, Inc. D/B/A Estech20110—
+2K100501Multifunctional Linear PenAtriCure, Inc.20109—
+2K061544Stellartech 100 Coagulation SystemStellartech Research Corp.20060—
+3K221358Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear…AtriCure, Inc.20220—
+3K190151COBRA Fusion Ablation SystemAtriCure, Inc.20190—
+3K160950MiniscavSedation Systems, LLC201701
+3K170329Basic, Dominant FlexModela AG201701
+3K130521Isolator Linear PenAtriCure, Inc.20133—
+3K120857Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc.20122—
+4K163408Isolator Multifunctional Linear PenAtriCure, Inc.20172—
+4K142084Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc.201411
+5K193162EPi-Sense Guided Coagulation System with VisiTraxAtriCure, Inc.20190—