FDA 510(k)

Aristotle 14 Guía; Aristotle 18 Guía; Aristotle 24 Guía; Volo 14 Guía; Zoom Wire 14 Guía

N.º K: K220398 · 2023-03-10

Fecha de decisión2023-03-10

Código de productoMOF

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 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 2023-03-10 under 510(k) number K220398. The device is classified under product code MOF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire?

Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire is a medical device that received FDA 510(k) clearance on 2023-03-10. The listed applicant is Scientia Vascular, LLC. The 510(k) number is K220398.

When did Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire receive FDA 510(k) clearance?

Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire received FDA 510(k) clearance on 2023-03-10, under 510(k) number K220398.

Who is the listed applicant for Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 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 Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire?

The FDA product code for Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire is MOF.

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Otros registros que enlistan a Scientia Vascular, LLC como solicitante

K210601Plato 17 Microcatheter K201760Zoom 14 Guidewire 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: MOF)

K254181Aristotle 65 MacrowireScientia Vascular K26075135 Helix GuidewirePiraeus Medical, Inc.K262424Willow 12 GuidewireArbor Endovascular, LLC K260223Aristotle Mini GuidewireScientia Vascular, Inc.K254006Drivewire 35 GuidewireRapid Medical Ltd.K253579Aristotle 14 Guía; Aristotle 18 Guía; Aristotle 24 Guía; Zoom Wire 14 GuíaScientia Vascular, Inc.

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.