K233959
- 510(k) number
- K233959
- Device name
- EPi-Ease Epicardial Access Device (EAS)
- Applicant
- AtriCure, Inc. OH · US
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2024-02-13
- Date received
- 2023-12-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K233959.pdf
Official FDA record: K233959
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.