FDA 510(k)

VX1

N.º K: K201298 · 2020-09-16

Fecha de decisión2020-09-16

Código de productoDQK

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

VX1 is the device name listed in this FDA 510(k) record. The listed applicant is Volta Medical. It received FDA 510(k) clearance on 2020-09-16 under 510(k) number K201298. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the VX1?

VX1 is a medical device that received FDA 510(k) clearance on 2020-09-16. The listed applicant is Volta Medical. The 510(k) number is K201298.

When did VX1 receive FDA 510(k) clearance?

VX1 received FDA 510(k) clearance on 2020-09-16, under 510(k) number K201298.

Who is the listed applicant for VX1?

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

What is the FDA product code for VX1?

The FDA product code for VX1 is DQK.

Otros registros que enlistan a Volta Medical como solicitante

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K251518Volta AF-Xplorer II K243812Volta AF-Xplorer K232616Volta AF-Xplorer K223516VX1+

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K261729EnSite™ X EP SystemAbbott Medical K262005Affera Integrated Mapping SystemMedtronic, Inc.K253692AVVIGO™+ Multi-Modality Guidance SystemBoston Scientific K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott Medical K252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.