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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 the device name listed in this FDA 510(k) record. The listed applicant is AtriCure, Inc.. It received FDA 510(k) clearance on 2024-02-13 under 510(k) 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. The listed applicant is AtriCure, Inc.. The 510(k) number is K233959.

When did EPi-Ease Epicardial Access Device (EAS) receive FDA 510(k) clearance?

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

Who is the listed applicant for EPi-Ease Epicardial Access Device (EAS)?

The FDA 510(k) record lists AtriCure, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 Devices (Code: DYB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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