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FDA 510(k)

EPi-Ease Epicardial Access Device (EAS)

K-Number: K233959 · 2024-02-13

ApplicantAtriCure, Inc.
Decision Date2024-02-13
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EPi-Ease Epicardial Access Device (EAS) is a medical device manufactured by AtriCure, Inc.. It received FDA 510(k) clearance on 2024-02-13 under approval number K233959. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPi-Ease Epicardial Access Device (EAS)?

EPi-Ease Epicardial Access Device (EAS) is a medical device that received FDA 510(k) clearance on 2024-02-13. It is manufactured by AtriCure, Inc.. The 510(k) number is K233959.

When was EPi-Ease Epicardial Access Device (EAS) approved by the FDA?

EPi-Ease Epicardial Access Device (EAS) received FDA 510(k) clearance on 2024-02-13, under approval number K233959.

What company makes EPi-Ease Epicardial Access Device (EAS)?

EPi-Ease Epicardial Access Device (EAS) is manufactured by AtriCure, Inc..

What is the FDA product code for EPi-Ease Epicardial Access Device (EAS)?

The FDA product code for EPi-Ease Epicardial Access Device (EAS) is DYB.

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Related PubMed Literature

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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