Medical Device Manufacturer · US , West Chester , OH

AtriCure, Inc.

59 submissions · 59 cleared · Since 2001
59
Total
59
Cleared
0
Denied

AtriCure, Inc. — FDA 510(k) Submissions

AtriCure, Inc. has submitted 59 FDA 510(k) premarket notifications since 2001, of which 59 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue, Clip, Implantable, Unit, Cryosurgical, Accessories, Device, Surgical, Cryogenic, Left Atrial Appendage Clip, Implantable . Use the specialty filter in the sidebar to narrow results.

59 devices
1–25 of 59
Isolator? Synergy? EnCompass Clamp and Guide system (OLH, OSH, GPM100)
K252056 · OCL Surgical Device, For... · Cardiovascular
Jul 2025 23d
cryoICE cryoXT cryoablation probe (cryoXT)
K250371 · GXH Device, Surgical, Cryogenic · Neurology
Apr 2025 59d
AtriClip PRO-Mini LAA Exclusion System (PROM)
K243860 · PZX Left Atrial Appendage... · Cardiovascular
Jan 2025 30d
AtriCure cryoICE BOX (ACM)
K243157 · GXH Device, Surgical, Cryogenic · Neurology
Oct 2024 29d
Isolator Synergy EnCapture Ablation System (EMH)
K234151 · OCL Surgical Device, For... · Cardiovascular
Aug 2024 242d
AtriClip FLEX-Mini LAA Exclusion System (ACHM)
K234125 · PZX Left Atrial Appendage... · Cardiovascular
Jul 2024 214d
EPi-Ease Epicardial Access Device (EAS)
K233959 · DYB Introducer, Catheter · Cardiovascular
Feb 2024 60d
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)
K233407 · PZX Left Atrial Appendage... · Cardiovascular
Nov 2023 28d
cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L)
K233170 · GXH Device, Surgical, Cryogenic · Neurology
Oct 2023 29d
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)
K221358 · OCL Surgical Device, For... · Cardiovascular
Dec 2022 233d
AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE
K210477 · OCL Surgical Device, For... · Cardiovascular
Jul 2021 157d
AtriCure Isolator? Synergy? Surgical Ablation System
K211311 · OCL Surgical Device, For... · Cardiovascular
May 2021 28d
AtriClip LAA Exclusion System
K210293 · PZX Left Atrial Appendage... · Cardiovascular
Mar 2021 29d
AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)
K200697 · GXH Device, Surgical, Cryogenic · Neurology
Dec 2020 281d
EPi-Sense Guided Coagulation System with VisiTrax
K193162 · OCL Surgical Device, For... · Cardiovascular
Dec 2019 28d
Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen
K192125 · OCL Surgical Device, For... · Cardiovascular
Nov 2019 90d
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip
K191413 · PZX Left Atrial Appendage... · Cardiovascular
Aug 2019 85d
Coolrail Linear Pen
K190587 · OCL Surgical Device, For... · Cardiovascular
Jul 2019 139d
COBRA Fusion Ablation System
K190151 · OCL Surgical Device, For... · Cardiovascular
Feb 2019 26d
Coolrail Linear Pen
K183065 · OCL Surgical Device, For... · Cardiovascular
Dec 2018 29d
AtriCure cryoICE cryoSPHERE cryoablation probe
K182565 · GXH Device, Surgical, Cryogenic · Neurology
Nov 2018 52d
ArtiClip LAA Exclusion System
K181474 · PZX Left Atrial Appendage... · Cardiovascular
Jun 2018 24d
AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF)
K180137 · GEH Unit, Cryosurgical,... · General & Plastic Surgery
Feb 2018 29d
AtriCure cryoICE cryo-ablation probe (CRYO2)
K180138 · GXH Device, Surgical, Cryogenic · Neurology
Feb 2018 29d
AtriClip FLEX-V
K180010 · FZP Clip, Implantable · General & Plastic Surgery
Jan 2018 29d
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