FDA 510(k)

AcQCross Qx Integrado Dilatador Transseptal/Agulha

Número K: K210685 · 2021-04-06

Data da decisão2021-04-06

Código do produtoDYB

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

AcQCross Qx Integrated Transseptal Dilator/Needle is the device name listed in this FDA 510(k) record. The listed applicant is Acutus Medical, Inc.. It received FDA 510(k) clearance on 2021-04-06 under 510(k) number K210685. 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 AcQCross Qx Integrated Transseptal Dilator/Needle?

AcQCross Qx Integrated Transseptal Dilator/Needle is a medical device that received FDA 510(k) clearance on 2021-04-06. The listed applicant is Acutus Medical, Inc.. The 510(k) number is K210685.

When did AcQCross Qx Integrated Transseptal Dilator/Needle receive FDA 510(k) clearance?

AcQCross Qx Integrated Transseptal Dilator/Needle received FDA 510(k) clearance on 2021-04-06, under 510(k) number K210685.

Who is the listed applicant for AcQCross Qx Integrated Transseptal Dilator/Needle?

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

What is the FDA product code for AcQCross Qx Integrated Transseptal Dilator/Needle?

The FDA product code for AcQCross Qx Integrated Transseptal Dilator/Needle is DYB.

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