Medical Device Manufacturer · US , West Chester , OH

AtriCure, Inc. - FDA 510(k) Cleared Devices

60 submissions · 60 cleared · Since 2001

Recent clearances: ACHM30 AtriClip FLEX-Mini LAA Exclusion System, Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100), cryoICE cryoXT cryoablation probe (cryoXT)

View 60 510(k) Devices ↓ Official Website

60

Total

60

Cleared

0

Denied

FDA 510(k) Regulatory Record - AtriCure, Inc. Neurology ✕

7 devices

1-7 of 7

Cleared Apr 10, 2025

cryoICE cryoXT cryoablation probe (cryoXT)

Neurology · 59d

Cleared Oct 29, 2024

AtriCure cryoICE BOX (ACM)

Neurology · 29d

Cleared Oct 26, 2023

cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP)

Neurology · 29d

Cleared Dec 23, 2020

AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE...

Neurology · 281d

Cleared Nov 09, 2018

AtriCure cryoICE cryoSPHERE cryoablation probe

Neurology · 52d

Cleared Feb 15, 2018

AtriCure cryoICE cryo-ablation probe (CRYO2)

Neurology · 29d

Cleared Nov 25, 2014

Atricure Cryo Module System

Neurology · 106d