Medical Device Manufacturer · US , West Chester , OH

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

59 submissions · 59 cleared · Since 2001

Total

Cleared

Denied

AtriCure, Inc. specializes in surgical devices for atrial fibrillation treatment and pain management. The company develops ablation systems, left atrial appendage exclusion devices, and minimally invasive surgical instruments. AtriCure operates with a manufacturing facility in West Chester, Ohio, and serves healthcare professionals globally.

AtriCure has received 59 FDA 510(k) clearances from 59 total submissions since 2001. The company focuses primarily on cardiovascular devices, including surgical ablation systems, LAA management solutions, and epicardial access tools. The latest clearance in 2025 demonstrates continued regulatory activity and product innovation.

Recent cleared devices include the Isolator® Synergy™ EnCompass Clamp system, AtriClip PRO-Mini LAA Exclusion System, and the EPi-Ease Epicardial Access Device. The company's portfolio spans concomitant surgical ablation therapy, hybrid AF therapy platforms, and cryo nerve block systems for pain management. AtriCure maintains a diverse product line addressing multiple cardiac surgical needs.

Explore the full list of cleared device names, product codes, and clearance dates in the 510(k) database.

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

59 devices

1-12 of 59