AtriCure, Inc.
FDA 510(k) & PMA Approved Devices — 34 products
Total Devices34
Categories7
Latest FDA decision2026-05-06
SEC Filings: 1 filings on record. Latest: 10-Q (2026-07-27). View on SEC EDGAR →
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| PMA | P100046 | Surgical cardiac ablation device, for treatment of atrial fibrillation | OCM | 2026-05-06 | View |
| PMA | P200002 | Surgical cardiac ablation device, for treatment of atrial fibrillation | OCM | 2026-05-06 | View |
| 510(k) | K252056 | Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100) | OCL | 2025-07-24 | View |
| 510(k) | K250371 | cryoICE cryoXT cryoablation probe (cryoXT) | GXH | 2025-04-10 | View |
| 510(k) | K243860 | AtriClip PRO-Mini LAA Exclusion System (PROM) | PZX | 2025-01-15 | View |
| 510(k) | K243157 | AtriCure cryoICE BOX (ACM) | GXH | 2024-10-29 | View |
| 510(k) | K234151 | Isolator Synergy EnCapture Ablation System (EMH) | OCL | 2024-08-27 | View |
| 510(k) | K234125 | AtriClip FLEX-Mini LAA Exclusion System (ACHM) | PZX | 2024-07-29 | View |
| 510(k) | K233959 | EPi-Ease Epicardial Access Device (EAS) | DYB | 2024-02-13 | View |
| 510(k) | 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 | 2023-11-02 | View |
| 510(k) | 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 | 2023-10-26 | View |
| 510(k) | 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 | 2022-12-30 | View |
| 510(k) | K210477 | AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE | OCL | 2021-07-26 | View |
| 510(k) | K211311 | AtriCure Isolator® Synergy™ Surgical Ablation System | OCL | 2021-05-28 | View |
| 510(k) | K210293 | AtriClip LAA Exclusion System | PZX | 2021-03-03 | View |
| 510(k) | K200697 | AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L) | GXH | 2020-12-23 | View |
| 510(k) | K193162 | EPi-Sense Guided Coagulation System with VisiTrax | OCL | 2019-12-13 | View |
| 510(k) | K192125 | Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen | OCL | 2019-11-04 | View |
| 510(k) | K191413 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip | PZX | 2019-08-21 | View |
| 510(k) | K190587 | Coolrail Linear Pen | OCL | 2019-07-24 | View |
No matching devices.
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