FDA 510(k)

AcQMap 3D Imaging and Mapping Catheter

Número K: K201341 · 2020-09-15

Data da decisão2020-09-15

Código do produtoMTD

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

AcQMap 3D Imaging and Mapping Catheter 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 2020-09-15 under 510(k) number K201341. The device is classified under product code MTD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AcQMap 3D Imaging and Mapping Catheter?

AcQMap 3D Imaging and Mapping Catheter is a medical device that received FDA 510(k) clearance on 2020-09-15. The listed applicant is Acutus Medical, Inc.. The 510(k) number is K201341.

When did AcQMap 3D Imaging and Mapping Catheter receive FDA 510(k) clearance?

AcQMap 3D Imaging and Mapping Catheter received FDA 510(k) clearance on 2020-09-15, under 510(k) number K201341.

Who is the listed applicant for AcQMap 3D Imaging and Mapping Catheter?

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 AcQMap 3D Imaging and Mapping Catheter?

The FDA product code for AcQMap 3D Imaging and Mapping Catheter is MTD.

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Dispositivos Relacionados (Código: MTD)

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