FDA 510(k) Applications Submitted by ATRICURE, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K073605 12/21/2007 ATRICURE COOLRAIL LINEAR PEN ATRICURE, INC.
K180010 01/02/2018 AtriClip FLEX-V AtriCure, Inc.
K150996 04/15/2015 AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip ATRICURE, INC.
K183065 11/05/2018 Coolrail Linear Pen AtriCure, Inc.
K193162 11/15/2019 EPi-Sense Guided Coagulation System with VisiTrax AtriCure, Inc.
K050459 02/23/2005 ATRICURE ISOLATOR TRANSPOLAR PEN ATRICURE, INC.
K061593 06/08/2006 ATRICURE ISOLATOR TRANSPOLAR PEN SYSTEM, MODELS ASU2, MAX1, MAX2 AND ASB1 ATRICURE, INC.
K063630 12/06/2006 ATRICURE ABLATION SYSTEM ATRICURE, INC.
K043579 12/28/2004 ATRICURE BIPOLAR SYSTEM ATRICURE, INC.
K052893 10/14/2005 ATRICURE TRANSPOLAR SYSTEM ATRICURE, INC.
K100501 02/22/2010 MULTIFUNCTIONAL LINEAR PEN ATRICURE, INC.
K101174 04/27/2010 ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMPS MODEL OLL2, OSL2, EMR2, EML2 ATRICURE, INC.
K121507 05/21/2012 ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE) ATRICURE, INC.
K082074 07/23/2008 ATRICURE CRYO1 CRYO-ABLATION PROBE ATRICURE, INC.
K122276 07/30/2012 ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP ATRICURE, INC.
K093679 11/27/2009 ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP, GILLINOV-COSGROVE SECTION GUIDE MODEL VARIOUS LAA0 ATRICURE, INC.
K110117 01/18/2011 ATRICURE BIPOLAR SYSTEM ATRICURE, INC.
K111020 04/12/2011 ATRICURE DISSECTOR ATRICURE, INC.
K112072 07/20/2011 ATRICURE CRYO MODULE SYSTEM ATRICURE, INC.
K122611 08/27/2012 COOLRAIL LINEAR PEN MODEL MCRI ATRICURE, INC.
K211311 04/30/2021 AtriCure Isolator« SynergyÖ Surgical Ablation System AtriCure, Inc.
K160454 02/18/2016 AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip ATRICURE, INC.
K181474 06/04/2018 ArtiClip LAA Exclusion System AtriCure, Inc.
K142120 08/04/2014 ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP ATRICURE, INC.
K142203 08/11/2014 Atricure Cryo Module System; cryoICE cryoablation probe ATRICURE, INC.
K142441 09/02/2014 cryoICE croablation probe ATRICURE, INC.
K182565 09/18/2018 AtriCure cryoICE cryoSPHERE cryoablation probe AtriCure, Inc.
K153500 12/07/2015 AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip Atricure, Inc.
K140058 01/10/2014 ATRICURE CRYO MODULE SYSTEM ATRICURE, INC.
K041681 06/21/2004 ATRICURE DISSECTOR ATRICURE, INC.
K020919 03/21/2002 ATRICURE BIPOLAR SYSTEM, MODELS ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 ATRICURE, INC.
K011722 06/04/2001 ATRICURE BIPOLAR COAGULATION SYSTEM ATRICURE, INC.
K210293 02/02/2021 AtriClip LAA Exclusion System AtriCure, Inc.
K180137 01/17/2018 AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF) AtriCure, Inc.
K180138 01/17/2018 AtriCure cryoICE cryo-ablation probe (CRYO2) AtriCure, Inc.
K190151 01/30/2019 COBRA Fusion Ablation System AtriCure, Inc.
K172742 09/12/2017 AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2) AtriCure, Inc.
K173031 09/28/2017 AtriClip LAA Exclusion System with Preloaded PRO╖V Clip AtriCure, Inc.
K130521 02/28/2013 ISOLATOR LINEAR PEN ATRICURE, INC.
K111042 04/15/2011 ATRICURE CRYO MODULE ATRICURE, INC.
K131107 04/19/2013 ATRICLIP GILLINOV-COSGROVE LAA CLIP ATRICURE, INC.


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