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. General & Plastic Surgery ✕

25 devices

1-12 of 25

Cleared Feb 15, 2018

AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM...

General & Plastic Surgery · 29d

Cleared Jan 31, 2018

AtriClip FLEX-V

General & Plastic Surgery · 29d

Cleared Oct 25, 2017

AtriClip LAA Exclusion System with Preloaded PRO·V Clip

General & Plastic Surgery · 27d

Cleared Oct 11, 2017

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)

General & Plastic Surgery · 29d

Cleared May 19, 2017

AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded...

General & Plastic Surgery · 179d

Cleared Mar 22, 2016

cryoFORM cryoICE cryoablation probe

General & Plastic Surgery · 216d

Cleared Mar 18, 2016

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip

General & Plastic Surgery · 29d

Cleared Jan 27, 2016

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip

General & Plastic Surgery · 51d

Cleared Jun 17, 2015

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip

General & Plastic Surgery · 63d

Cleared Oct 29, 2014

cryoICE croablation probe

General & Plastic Surgery · 57d

Cleared Aug 28, 2014

ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP

General & Plastic Surgery · 24d

Cleared Jan 24, 2014

ATRICURE CRYO MODULE SYSTEM

General & Plastic Surgery · 14d