AtriCure, Inc.
Medical device manufacturer in Mason, OH.
59510(k) clearances
2PMA approvals
13recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K252056 | Isolator® Synergy EnCompass Clamp and Guide system (OLH, OSH, GPM100)OCL · Special | 07/24/2025SE |
| K250371 | cryoICE cryoXT cryoablation probe (cryoXT)GXH · Traditional | 04/10/2025SE |
| K243860 | AtriClip PRO-Mini LAA Exclusion System (PROM)PZX · Special | 01/15/2025SE |
| K243157 | AtriCure cryoICE BOX (ACM)GXH · Special | 10/29/2024SE |
| K234151 | Isolator Synergy EnCapture Ablation System (EMH)OCL · Traditional | 08/27/2024SE |
| K234125 | AtriClip FLEX-Mini LAA Exclusion System (ACHM)PZX · Traditional | 07/29/2024SE |
| K233959 | EPi-Ease Epicardial Access Device (EAS)DYB · Traditional | 02/13/2024SE |
| K233407 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA…PZX · Special | 11/02/2023SE |
| K233170 | cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe…GXH · Special | 10/26/2023SE |
| K221358 | Isolator® Linear Pen (MLP1); Isolator® Transpolar Pen (MAX1, MAX5), Coolrail® Linear…OCL · Traditional | 12/30/2022SE |
| K210477 | AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDEOCL · Traditional | 07/26/2021SE |
| K211311 | AtriCure Isolator® Synergy Surgical Ablation SystemOCL · Special | 05/28/2021SE |
| K210293 | AtriClip LAA Exclusion SystemPZX · Special | 03/03/2021SE |
| K200697 | AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation…GXH · Traditional | 12/23/2020SE |
| K193162 | EPi-Sense Guided Coagulation System with VisiTraxOCL · Special | 12/13/2019SE |
| K192125 | Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear PenOCL · Special | 11/04/2019SE |
| K191413 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA…PZX · Traditional | 08/21/2019SE |
| K190587 | Coolrail Linear PenOCL · Special | 07/24/2019SE |
| K190151 | COBRA Fusion Ablation SystemOCL · Special | 02/25/2019SE |
| K183065 | Coolrail Linear PenOCL · Special | 12/04/2018SE |
| K182565 | AtriCure cryoICE cryoSPHERE cryoablation probeGXH · Special | 11/09/2018SE |
| K181474 | ArtiClip LAA Exclusion SystemPZX · Special | 06/28/2018SE |
| K180138 | AtriCure cryoICE cryo-ablation probe (CRYO2)GXH · Special | 02/15/2018SE |
| K180137 | AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation…GEH · Special | 02/15/2018SE |
| K180010 | AtriClip FLEX-VFZP · Special | 01/31/2018SE |
| K173031 | AtriClip LAA Exclusion System with Preloaded PRO·V ClipFZP · Special | 10/25/2017SE |
| K172742 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)FZP · Special | 10/11/2017SE |
| K163261 | AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded…FZP · Traditional | 05/19/2017SE |
| K163408 | Isolator Multifunctional Linear PenOCL · Special | 01/03/2017SE |
| K152337 | cryoFORM cryoICE cryoablation probeGEH · Traditional | 03/22/2016SE |
| K160454 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove ClipFZP · Special | 03/18/2016SE |
| K153500 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V ClipFZP · Traditional | 01/27/2016SE |
| K150996 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove ClipFZP · Special | 06/17/2015SE |
| K142203 | Atricure Cryo Module System; cryoICE cryoablation probeGXH · Traditional | 11/25/2014SE |
| K142441 | cryoICE croablation probeGEH · Special | 10/29/2014SE |
| K142120 | Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipFZP · Special | 08/28/2014SE |
| K140058 | Atricure Cryo Module SystemGEH · Special | 01/24/2014SE |
| K131107 | Atriclip Gillinov-Cosgrove Laa ClipFZP · Special | 05/14/2013SE |
| K130521 | Isolator Linear PenOCL · Special | 04/05/2013SE |
| K122611 | Coolrail Linear Pen Model McriOCL · Special | 09/26/2012SE |
| K122276 | Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipFZP · Special | 08/29/2012SE |
| K121507 | Atricure Cryo Module System (Acm, CRYO1, and Cryoice)GEH · Traditional | 06/06/2012SE |
| K112072 | Atricure Cryo Module SystemGEH · Traditional | 08/03/2011SE |
| K111020 | Atricure DissectorFTD · Special | 06/09/2011SE |
| K111042 | Atricure Cryo ModuleGEH · Traditional | 05/26/2011SE |
| K110117 | Atricure Bipolar SystemOCL · Traditional | 04/08/2011SE |
| K101174 | Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model OLL2…OCL · Traditional | 11/12/2010SE |
| K100501 | Multifunctional Linear PenOCL · Traditional | 06/18/2010SE |
| K093679 | Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove…FZP · Traditional | 06/10/2010SE |
| K082074 | Atricure CRYO1 Cryo-Ablation ProbeGEH · Traditional | 03/02/2009SE |
| K073605 | Atricure Coolrail Linear PenOCL · Traditional | 03/11/2008SE |
| K043579 | Atricure Bipolar SystemOCL · Traditional | 07/05/2007SE |
| K063630 | Atricure Ablation SystemGEI · Traditional | 01/26/2007SE |
| K061593 | Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1OCL · Traditional | 07/12/2006SE |
| K052893 | Atricure Transpolar SystemGEI · Traditional | 10/25/2005SE |
| K050459 | Atricure Isolator Transpolar PenOCL · Traditional | 06/13/2005SE |
| K041681 | Atricure DissectorFTD · Traditional | 07/01/2004SE |
| K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1GEI · Special | 04/19/2002SE |
| K011722 | Atricure Bipolar Coagulation SystemGEI · Traditional | 08/30/2001SE |
PMA approvals
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0928-2024 Class II | Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect… | 11/28/2023Open, Classified |
| Z-0927-2024 Class II | Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect… | 11/28/2023Open, Classified |
| Z-1887-2019 Class II | EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Product Usage:…The sterile package seal for the Epi-Sense Guided Coagulation System may be compromised, and has a… | 05/29/2019Terminated |
| Z-0832-2019 Class II | COBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MIThere is a potential for patients undergoing ablation to experience an elevated risk for TE; during… | 01/22/2019Terminated |
| Z-0831-2019 Class II | COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001SThere is a potential for patients undergoing ablation to experience an elevated risk for TE; during… | 01/22/2019Terminated |
| Z-0830-2019 Class II | COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001There is a potential for patients undergoing ablation to experience an elevated risk for TE; during… | 01/22/2019Terminated |
| Z-0829-2019 Class II | COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002There is a potential for patients undergoing ablation to experience an elevated risk for TE; during… | 01/22/2019Terminated |
| Z-1148-2017 Class II | AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A single PRO2…A complaint of the PRO2 jaw breaking prior to surgery being performed. | 11/30/2016Terminated |
| Z-0653-2017 Class II | COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion…Due to product design and process control, part of the device can separate and remain behind when the device… | 09/22/2016Terminated |
| Z-0377-2017 Class II | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for…There is a potential for a component failure of the device which could necessitate medical intervention. | 09/22/2016Terminated |
| Z-0895-2015 Class II | Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek pouches…Affected product may have compromised sterility due to packaging defects. It was determined that some… | 11/21/2014Terminated |
| Z-1209-2014 Class II | Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive, West…The firm was notified by a customer of a cracked spring in the handle of the RCD1 device. | 01/23/2014Terminated |
| Z-0912-2013 Class II | Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac…Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling. | 01/14/2013Terminated |