FDA 510(k)

AcQCross Qx Integrado Dilatador/Aguja Transseptal

N.º K: K220047 · 2022-02-08

Fecha de decisión2022-02-08

Código de productoDYB

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del 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 2022-02-08 under 510(k) number K220047. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

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 2022-02-08. The listed applicant is Acutus Medical, Inc.. The 510(k) number is K220047.

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 2022-02-08, under 510(k) number K220047.

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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Fuente oficial

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