← Product Code OCM · P200002

# EPi-Sense Guided Coagulation System (P200002)

_AtriCure, Inc. · OCM · Apr 28, 2021 · Cardiovascular · APPR_

**Canonical URL:** https://fda.innolitics.com/device/P200002

## Device Facts

- **Applicant:** AtriCure, Inc.
- **Product Code:** OCM
- **Decision Date:** Apr 28, 2021
- **Decision:** APPR
- **Device Class:** Class 3
- **Review Panel:** Cardiovascular

## Regulatory Identification

Surgical cardiac ablation for the treatment of atrial fibrillation.

---

**Source:** [https://fda.innolitics.com/device/P200002](https://fda.innolitics.com/device/P200002)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a PMA](https://innolitics.com/services/regulatory/), [a 510(k)](https://innolitics.com/services/510ks/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com