FDA 510(k)

Zoom 14 Guidewire

N.º K: K201760 · 2020-07-29

Fecha de decisión2020-07-29

Código de productoDQX

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Zoom 14 Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Scientia Vascular, LLC. It received FDA 510(k) clearance on 2020-07-29 under 510(k) number K201760. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Zoom 14 Guidewire?

Zoom 14 Guidewire is a medical device that received FDA 510(k) clearance on 2020-07-29. The listed applicant is Scientia Vascular, LLC. The 510(k) number is K201760.

When did Zoom 14 Guidewire receive FDA 510(k) clearance?

Zoom 14 Guidewire received FDA 510(k) clearance on 2020-07-29, under 510(k) number K201760.

Who is the listed applicant for Zoom 14 Guidewire?

The FDA 510(k) record lists Scientia Vascular, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Zoom 14 Guidewire?

The FDA product code for Zoom 14 Guidewire is DQX.

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Otros registros que enlistan a Scientia Vascular, LLC como solicitante

K220398Aristotle 14 Guía; Aristotle 18 Guía; Aristotle 24 Guía; Volo 14 Guía; Zoom Wire 14 Guía K210601Plato 17 Microcatheter K192783Aristóteles 24 Guía, 200cm, Perfil Suave; Aristóteles 24 Guía, 200cm, Perfil Estándar; Aristóteles 24 Guía, 200cm, Perfil de Soporte K183608Aristóteles 18 Guía, 200cm, Perfil Suave; Aristóteles 18 Guía, 200cm, Perfil Estándar; Aristóteles 18 Guía, 200cm, Perfil de Soporte K181828Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile K173235Aristotle 14 Guía, 200cm, Perfil Suave, Aristotle 14 Guía, 200cm, Perfil de Soporte, Aristotle 14 Guía, 300cm, Perfil Suave, Aristotle 14 Guía, 300cm, Perfil de Soporte

Ver todos los 8 dispositivos →

Dispositivos relacionados (Código: DQX)

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Fuente oficial

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