# P200002: EPi-Sense Guided Coagulation System

- Pathway: PMA
- Applicant: AtriCure, Inc.
- Decided: Apr 28, 2021 after 482 days
- Product code: OCM (Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation)
- Device class: 3
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

Source page: https://510kreport.com/device/P200002
Methodology: https://510kreport.com/methodology