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. |
| K243860 |
12/16/2024 |
AtriClip PRO-Mini LAA Exclusion System (PROM) |
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. |
| K233170 |
09/27/2023 |
cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L) |
AtriCure, Inc. |
| K252056 |
07/01/2025 |
Isolator« SynergyÖ EnCompass Clamp and Guide system (OLH, OSH, GPM100) |
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. |
| K233959 |
12/15/2023 |
EPi-Ease Epicardial Access Device (EAS) |
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. |
| K180138 |
01/17/2018 |
AtriCure cryoICE cryo-ablation probe (CRYO2) |
AtriCure, Inc. |
| K180137 |
01/17/2018 |
AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF) |
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. |
| K250371 |
02/10/2025 |
cryoICE cryoXT cryoablation probe (cryoXT) |
AtriCure, Inc. |
| K243157 |
09/30/2024 |
AtriCure cryoICE BOX (ACM) |
AtriCure, Inc. |
| K233407 |
10/05/2023 |
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH2); AtriClip LAA Exclusion Syst |
AtriCure, Inc. |
| K234125 |
12/28/2023 |
AtriClip FLEX-Mini LAA Exclusion System (ACHM) |
AtriCure, Inc. |
|
|
