Chrysalis Intelligence · Sponsors · AtriCure, Inc.

AtriCure, Inc.

Mason, OH, US · 14 510(k) clearances · 24 PMAs · 2 recalls

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Total clearances
14
2020-12-23 → 2025-07-24
Last 12 months
0
Product codes
4
Most recent
2025-07-24
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue Class II General, Plastic Surgery 5 2025-07-24
GXH — — — 4 2025-04-10
PZX Left Atrial Appendage Clip, Implantable Class II General, Plastic Surgery 4 2025-01-15
DYB Introducer, Catheter Class II Cardiovascular 1 2024-02-13
Class III

PMA approvals (24)

Total PMA records
24
Originals + supplements
Distinct product codes
1
First decision
2020-08-14
Most recent
2026-05-06
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-05-06 P200002-S014 EPi-Sense and EPi-Sense ST Guided Coagulation System Special (Immediate Track) OCM Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation Unknown
2026-05-06 P100046-S020 Synergy Ablation System Special (Immediate Track) OCM Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation Unknown
2025-11-14 P200002-S013 EPi-Sense ST Coagulation System Real-Time Process OCM Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation Unknown
2025-10-07 P200002-S012 EPi-Sense Guided Coagulation System Normal 180 Day Track No User Fee OCM Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation Unknown
2025-06-17 P200002-S011 EPi-Sense Guided Coagulation System Normal 180 Day Track No User Fee OCM Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation Unknown
2025-06-17 P100046-S019 Synergy Ablation System Normal 180 Day Track No User Fee OCM Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation Unknown
2025-03-03 P200002-S010 EPi-Sense and EPi-Sense ST Guided Coagulation System Special (Immediate Track) OCM Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation Unknown
2024-08-28 P200002-S009 Cannula with Guide Normal 180 Day Track OCM Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation Unknown
2024-03-15 P100046-S018 Synergy Ablation System Special (Immediate Track) OCM Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation Unknown
2023-12-11 P200002-S008 EPi-Sense Guided Coagulation System and EPi-Sense ST Coagulation System Normal 180 Day Track No User Fee OCM Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation Unknown
2023-11-22 P200002-S007 EPi-Sense Guided Coagulation System Real-Time Process OCM Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation Unknown
2023-11-22 P100046-S017 Synergy Ablation System Real-Time Process OCM Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation Unknown
2023-05-25 P200002-S006 EPi-Sense ST RF Cable 30-Day Notice OCM Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation Unknown
2023-05-19 P200002-S005 Multifunctional Ablation Generator (MAG) Special (Immediate Track) OCM Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation Unknown
2023-05-19 P100046-S016 Multifunctional Ablation Generator (MAG) Special (Immediate Track) OCM Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation Unknown
2023-03-23 P100046-S015 AtriCure Isolator Clamp, AtriCure Long Clamp, AtriCure Synergy Clamp 30-Day Notice OCM Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation Unknown
2022-12-27 P200002-S004 EPi-Sense®, EPi-Sense ST™ Guided Coagulation System Normal 180 Day Track OCM Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation Unknown
2022-11-15 P100046-S013 AtriCure Synergy Ablation System Normal 180 Day Track OCM Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation Unknown
2022-10-13 P200002-S003 EPi-Sense® Guided Coagulation System and EPi-Sense ST™ Coagulation System Normal 180 Day Track No User Fee OCM Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation Unknown
2022-08-16 P200002-S002 EPi-Sense® ST Guided Coagulation System Normal 180 Day Track OCM Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation Unknown
2022-01-10 P200002-S001 EPi-Sense Guided Coagulation System Normal 180 Day Track No User Fee OCM Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation Unknown
2021-04-28 P200002 EPi-Sense Guided Coagulation System Original OCM Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation Unknown
2020-11-20 P100046-S011 AtriCure Synergy Ablation System Normal 180 Day Track OCM Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation Unknown
2020-08-14 P100046-S012 Synergy Ablation System 30-Day Notice OCM Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation Unknown
Safety

Recalls (2)

Class I (serious)
0
Risk of injury / death
Total recalls
2
Currently ongoing
2
Most recent
2023-11-28
DateSeverityStatusRecall # ProductCodeReason
2023-11-28 Class II Ongoing 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 we…
2023-11-28 Class II Ongoing 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 we…
Filings

All 510(k) clearances (14)

Date K-number Device Code Class Specialty
2025-07-24 K252056 Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100) OCL Class II General, Plastic Surgery
2025-04-10 K250371 cryoICE cryoXT cryoablation probe (cryoXT) GXH — —
2025-01-15 K243860 AtriClip PRO-Mini LAA Exclusion System (PROM) PZX Class II General, Plastic Surgery
2024-10-29 K243157 AtriCure cryoICE BOX (ACM) GXH — —
2024-08-27 K234151 Isolator Synergy EnCapture Ablation System (EMH) OCL Class II General, Plastic Surgery
2024-07-29 K234125 AtriClip FLEX-Mini LAA Exclusion System (ACHM) PZX Class II General, Plastic Surgery
2024-02-13 K233959 EPi-Ease Epicardial Access Device (EAS) DYB Class II Cardiovascular
2023-11-02 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 Class II General, Plastic Surgery
2023-10-26 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 — —
2022-12-30 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 Class II General, Plastic Surgery
2021-07-26 K210477 AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE OCL Class II General, Plastic Surgery
2021-05-28 K211311 AtriCure Isolator® Synergy™ Surgical Ablation System OCL Class II General, Plastic Surgery
2021-03-03 K210293 AtriClip LAA Exclusion System PZX Class II General, Plastic Surgery
2020-12-23 K200697 AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L) GXH — —
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence