FDA 510(k)

PeriCross™ Epicardial Access Kit

Número K: K243954 · 2025-04-24

Data da decisão2025-04-24

Código do produtoDYB

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

PeriCross™ Epicardial Access Kit is the device name listed in this FDA 510(k) record. The listed applicant is Circa Scientific, Inc.. It received FDA 510(k) clearance on 2025-04-24 under 510(k) number K243954. 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 PeriCross™ Epicardial Access Kit?

PeriCross™ Epicardial Access Kit is a medical device that received FDA 510(k) clearance on 2025-04-24. The listed applicant is Circa Scientific, Inc.. The 510(k) number is K243954.

When did PeriCross™ Epicardial Access Kit receive FDA 510(k) clearance?

PeriCross™ Epicardial Access Kit received FDA 510(k) clearance on 2025-04-24, under 510(k) number K243954.

Who is the listed applicant for PeriCross™ Epicardial Access Kit?

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

What is the FDA product code for PeriCross™ Epicardial Access Kit?

The FDA product code for PeriCross™ Epicardial Access Kit is DYB.

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Fonte oficial

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