AtriCure, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100), cryoICE cryoXT cryoablation probe (cryoXT), AtriClip PRO-Mini LAA Exclusion System (PROM)
59
Total
59
Cleared
0
Denied
FDA 510(k) Regulatory Record - AtriCure, Inc. Cardiovascular ✕
27 devices
Cleared
Jul 24, 2025
Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)
Cardiovascular
23d
Cleared
Jan 15, 2025
AtriClip PRO-Mini LAA Exclusion System (PROM)
Cardiovascular
30d
Cleared
Aug 27, 2024
Isolator Synergy EnCapture Ablation System (EMH)
Cardiovascular
242d
Cleared
Jul 29, 2024
AtriClip FLEX-Mini LAA Exclusion System (ACHM)
Cardiovascular
214d
Cleared
Feb 13, 2024
EPi-Ease Epicardial Access Device (EAS)
Cardiovascular
60d
Cleared
Nov 02, 2023
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0)
Cardiovascular
28d
Cleared
Dec 30, 2022
Isolator® Linear Pen (MLP1)
Cardiovascular
233d
Cleared
Jul 26, 2021
AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE
Cardiovascular
157d
Cleared
May 28, 2021
AtriCure Isolator® Synergy™ Surgical Ablation System
Cardiovascular
28d
Cleared
Mar 03, 2021
AtriClip LAA Exclusion System
Cardiovascular
29d
Cleared
Dec 13, 2019
EPi-Sense Guided Coagulation System with VisiTrax
Cardiovascular
28d
Cleared
Nov 04, 2019
Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen
Cardiovascular
90d