FDA 510(k)

EPi-Ease Epicardial Access Device (EAS)

Número K: K233959 · 2024-02-13

Data da decisão2024-02-13

Código do produtoDYB

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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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Fonte oficial

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