AtriCure, Inc.
Mason, OH, US
ATRICURE, INC. appears in FDA device records in Mason, OH. FDA records list 59 510(k) clearances between and , 35 PMA records and 2 registered establishments. As of , FDA records show 13 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 59FDA records hold 59 510(k) clearances for AtriCure, Inc. between 2001 and 2025. The busiest year on record is 2018, with 6. The most recent is 2025, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2002 | 1 |
| 2004 | 1 |
| 2005 | 2 |
| 2006 | 1 |
| 2007 | 2 |
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 3 |
| 2011 | 4 |
| 2012 | 3 |
| 2013 | 2 |
| 2014 | 4 |
| 2015 | 1 |
| 2016 | 3 |
| 2017 | 4 |
| 2018 | 6 |
| 2019 | 5 |
| 2020 | 1 |
| 2021 | 3 |
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 4 |
| 2025 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252056 | Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100) | OCL | Substantially Equivalent | |
| K250371 | cryoICE cryoXT cryoablation probe (cryoXT) | GXH | Substantially Equivalent | |
| K243860 | AtriClip PRO-Mini LAA Exclusion System (PROM) | PZX | Substantially Equivalent | |
| K243157 | AtriCure cryoICE BOX (ACM) | GXH | Substantially Equivalent | |
| K234151 | Isolator Synergy EnCapture Ablation System (EMH) | OCL | Substantially Equivalent | |
| K234125 | AtriClip FLEX-Mini LAA Exclusion System (ACHM) | PZX | Substantially Equivalent | |
| K233959 | EPi-Ease Epicardial Access Device (EAS) | DYB | Substantially Equivalent | |
| K233407 | 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 System with preloaded Gillinov-Cosgrove Clip (PRO1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2); AtriClip PRO-V LAA Exclusion System (PROV); AtriClip Flex-V LAA Exclusion System with preloaded V Clip (ACHV) | PZX | Substantially Equivalent | |
| K233170 | cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L) | GXH | Substantially Equivalent | |
| K221358 | Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1) | OCL | Substantially Equivalent | |
| K210477 | AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE | OCL | Substantially Equivalent | |
| K211311 | AtriCure Isolator® Synergy™ Surgical Ablation System | OCL | Substantially Equivalent | |
| K210293 | AtriClip LAA Exclusion System | PZX | Substantially Equivalent | |
| K200697 | AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L) | GXH | Substantially Equivalent | |
| K193162 | EPi-Sense Guided Coagulation System with VisiTrax | OCL | Substantially Equivalent | |
| K192125 | Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen | OCL | Substantially Equivalent | |
| K191413 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip | PZX | Substantially Equivalent | |
| K190587 | Coolrail Linear Pen | OCL | Substantially Equivalent | |
| K190151 | COBRA Fusion Ablation System | OCL | Substantially Equivalent | |
| K183065 | Coolrail Linear Pen | OCL | Substantially Equivalent | |
| K182565 | AtriCure cryoICE cryoSPHERE cryoablation probe | GXH | Substantially Equivalent | |
| K181474 | ArtiClip LAA Exclusion System | PZX | Substantially Equivalent | |
| K180138 | AtriCure cryoICE cryo-ablation probe (CRYO2) | GXH | Substantially Equivalent | |
| K180137 | AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF) | GEH | Substantially Equivalent | |
| K180010 | AtriClip FLEX-V | FZP | Substantially Equivalent | |
| K173031 | AtriClip LAA Exclusion System with Preloaded PRO·V Clip | FZP | Substantially Equivalent | |
| K172742 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2) | FZP | Substantially Equivalent | |
| K163261 | AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip | FZP | Substantially Equivalent | |
| K163408 | Isolator Multifunctional Linear Pen | OCL | Substantially Equivalent | |
| K152337 | cryoFORM cryoICE cryoablation probe | GEH | Substantially Equivalent | |
| K160454 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip | FZP | Substantially Equivalent | |
| K153500 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip | FZP | Substantially Equivalent | |
| K150996 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip | FZP | Substantially Equivalent | |
| K142203 | Atricure Cryo Module System; cryoICE cryoablation probe | GXH | Substantially Equivalent | |
| K142441 | cryoICE croablation probe | GEH | Substantially Equivalent | |
| K142120 | ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP | FZP | Substantially Equivalent | |
| K140058 | ATRICURE CRYO MODULE SYSTEM | GEH | Substantially Equivalent | |
| K131107 | ATRICLIP GILLINOV-COSGROVE LAA CLIP | FZP | Substantially Equivalent | |
| K130521 | ISOLATOR LINEAR PEN | OCL | Substantially Equivalent | |
| K122611 | COOLRAIL LINEAR PEN MODEL MCRI | OCL | Substantially Equivalent | |
| K122276 | ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP | FZP | Substantially Equivalent | |
| K121507 | ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE) | GEH | Substantially Equivalent | |
| K112072 | ATRICURE CRYO MODULE SYSTEM | GEH | Substantially Equivalent | |
| K111020 | ATRICURE DISSECTOR | FTD | Substantially Equivalent | |
| K111042 | ATRICURE CRYO MODULE | GEH | Substantially Equivalent | |
| K110117 | ATRICURE BIPOLAR SYSTEM | OCL | Substantially Equivalent | |
| K101174 | ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMPS MODEL OLL2, OSL2, EMR2, EML2 | OCL | Substantially Equivalent | |
| K100501 | MULTIFUNCTIONAL LINEAR PEN | OCL | Substantially Equivalent | |
| K093679 | ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP, GILLINOV-COSGROVE SECTION GUIDE MODEL VARIOUS LAA0 | FZP | Substantially Equivalent | |
| K082074 | ATRICURE CRYO1 CRYO-ABLATION PROBE | GEH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011706110 | 3011706110 | ATRICURE, INC. | 7555 Innovation Way, Mason, OH 45040 US | 2026 | and 9 more, listed in full below |
| 3020954746 | 3020954746 | AtriCure, Inc. | 3875 Hopyard Rd., Pleasanton, CA 94588 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GEACannula, Surgical, General & Plastic Surgery
- DQYCatheter, Percutaneous
- FZPClip, Implantable
- FZTCutter, Surgical
- GXHDevice, Surgical, Cryogenic
- GDIDissector, Surgical, General & Plastic Surgery
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- FZXGuide, Surgical, Instrument
- HCFInstrument, Ligature Passing And Knot Tying
- MDMInstrument, Manual, Surgical, General Use
- DWSInstruments, Surgical, Cardiovascular
- DYBIntroducer, Catheter
- FTDLamp, Surgical
- PZXLeft Atrial Appendage Clip, Implantable
- HMFStand, Instrument, Ac-Powered, Ophthalmic
- OCMSurgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
- OCLSurgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
- GATSuture, Nonabsorbable, Synthetic, Polyethylene
- GEHUnit, Cryosurgical, Accessories
- DQXWire, Guide, Catheter
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0928-2024 | Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056 | AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect tank hose assemblies. These tank hose assemblies were provided with an outer sheathing that does not have required pin perforations and the inner tube of the hose is not the correct material. | Class II | Open, Classified | |
| Z-0927-2024 | Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053 | AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect tank hose assemblies. These tank hose assemblies were provided with an outer sheathing that does not have required pin perforations and the inner tube of the hose is not the correct material. | Class II | Open, Classified | |
| Z-1887-2019 | EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Product Usage: The EPi-Sense Guided Coagulation System with VisiTrax, consists of a sterile, single-use, disposable coagulation electrode device (1cm, 2cm, and 3cm sizes provided) intended to be used to coagulate cardiac tissue. The flexible, cooled electrode device, with a suction stabilizer feature, transmits radiofrequency (RF) energy from an Electrosurgical Generator (non-sterile, re-useable) connected through an Instrument Cable (sterile). A temporary sensing electrode feature may be used with an off-the-shelf electrogram recording system with the use of an additional instrument cable (non-sterile). An accessory Cannula may be used to facilitate coagulation device access and visibility of the heart. The EPi-Sense Guided Coagulation System with VisiTrax technology is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy using thoracoscopic, endoscopic, and laparoscopic surgical techniques and may be used for temporary cardiac signal sensing and recording during surgery when connected to a temporary external recording device. | The sterile package seal for the Epi-Sense Guided Coagulation System may be compromised, and has a worst-case reasonable harm of infection if used. | Class II | Terminated | |
| Z-0832-2019 | COBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI | There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not utilized. | Class II | Terminated | |
| Z-0831-2019 | COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S | There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not utilized. | Class II | Terminated | |
| Z-0830-2019 | COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001 | There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not utilized. | Class II | Terminated | |
| Z-0829-2019 | COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002 | There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not utilized. | Class II | Terminated | |
| Z-1148-2017 | AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A single PRO2 device is packaged in a conventional thermoformed polyethylene terephthalate glycol (PETG) tray with a Tyvek lid. A single-walled non-corrugated box completes the single unit package. Six (6) single unit PRO2 devices are packaged into one (1) corrugate shipper box. | A complaint of the PRO2 jaw breaking prior to surgery being performed. | Class II | Terminated | |
| Z-0653-2017 | COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion Magnetic Retriever System. Model Numbers: 700-001, 700-001S, 700-001MI, 700-002, and 700-003. Intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the Estech Electrosurgical unit (ESU). | Due to product design and process control, part of the device can separate and remain behind when the device is removed that can potentially cause permanent impairment or damage to body function or structure. | Class II | Terminated | |
| Z-0377-2017 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for the occlusion of the heart's left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures. | There is a potential for a component failure of the device which could necessitate medical intervention. | Class II | Terminated | |
| Z-0895-2015 | Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek pouches Product Usage: Cryogenic probe for cardiac ablation surgery. The CryoICE cryoablation probe is a sterile, single use device intended to use in the cryosurgical treatment of cardiac arrhythmias. The probe freezes target tissues, creating an inflammatory response (cryo-necrosis) that blocks the electrical conduction pathway. | Affected product may have compromised sterility due to packaging defects. It was determined that some mishandling of the product during the packaging process could inadvertently damage the sterile barrier. | Class II | Terminated | |
| Z-1209-2014 | Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive, West Chester, OH 45069. The Reusable Clip Applier (Applier) is intended to be used to deploy the Gillinov-Cosgrove LAA Clip (Clip). The Gillinov-Cosgrove LAA Clip (Clip) is an implantable device used for occlusion of the left atrial appendage. | The firm was notified by a customer of a cracked spring in the handle of the RCD1 device. | Class II | Terminated | |
| Z-0912-2013 | Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the AtriCure Ablation and Sensing Unit or for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device. | Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain