Atricure Inc
Summary
- Total Recalls
- 13
- 510(k) Clearances
- 59
- Inspections
- 10
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0927-2024 | Class II | Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053 | November 28, 2023 |
| Z-0928-2024 | Class II | Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056 | November 28, 2023 |
| Z-1887-2019 | Class II | EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Product Usage: The EPi-Sense | May 29, 2019 |
| Z-0831-2019 | Class II | COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S | January 22, 2019 |
| Z-0832-2019 | Class II | COBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI | January 22, 2019 |
| Z-0829-2019 | Class II | COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002 | January 22, 2019 |
| Z-0830-2019 | Class II | COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001 | January 22, 2019 |
| Z-1148-2017 | Class II | AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A single PRO2 device is pack | November 30, 2016 |
| Z-0377-2017 | Class II | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for the occlusi | September 22, 2016 |
| Z-0653-2017 | Class II | COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion Magnetic Retriev | September 22, 2016 |
| Z-0895-2015 | Class II | Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek pouches Product Usag | November 21, 2014 |
| Z-1209-2014 | Class II | Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive, West Chester, OH 45069 | January 23, 2014 |
| Z-0912-2013 | Class II | Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac tissues during | January 14, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K252056 | Isolator® Synergy EnCompass Clamp and Guide system (OLH, OSH, GPM100) | July 24, 2025 |
| K250371 | cryoICE cryoXT cryoablation probe (cryoXT) | April 10, 2025 |
| K243860 | AtriClip PRO-Mini LAA Exclusion System (PROM) | January 15, 2025 |
| K243157 | AtriCure cryoICE BOX (ACM) | October 29, 2024 |
| K234151 | Isolator Synergy EnCapture Ablation System (EMH) | August 27, 2024 |
| K234125 | AtriClip FLEX-Mini LAA Exclusion System (ACHM) | July 29, 2024 |
| K233959 | EPi-Ease Epicardial Access Device (EAS) | February 13, 2024 |
| K233407 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA Exclusion S | November 2, 2023 |
| K233170 | cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); | October 26, 2023 |
| K221358 | Isolator® Linear Pen (MLP1); Isolator® Transpolar Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Is | December 30, 2022 |
| K210477 | AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE | July 26, 2021 |
| K211311 | AtriCure Isolator® Synergy Surgical Ablation System | May 28, 2021 |
| K210293 | AtriClip LAA Exclusion System | March 3, 2021 |
| K200697 | AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS | December 23, 2020 |
| K193162 | EPi-Sense Guided Coagulation System with VisiTrax | December 13, 2019 |
| K192125 | Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen | November 4, 2019 |
| K191413 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System w | August 21, 2019 |
| K190587 | Coolrail Linear Pen | July 24, 2019 |
| K190151 | COBRA Fusion Ablation System | February 25, 2019 |
| K183065 | Coolrail Linear Pen | December 4, 2018 |