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FDA 510(k)

DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ Contrast Reduction System

N.º K: K190102 · 2019-10-17

SolicitanteOsprey Medical, Inc.
Fecha de decisión2019-10-17
Código de productoDXT
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ Contrast Reduction System is the device name listed in this FDA 510(k) record. The listed applicant is Osprey Medical, Inc.. It received FDA 510(k) clearance on 2019-10-17 under 510(k) number K190102. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ Contrast Reduction System?

DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ Contrast Reduction System is a medical device that received FDA 510(k) clearance on 2019-10-17. The listed applicant is Osprey Medical, Inc.. The 510(k) number is K190102.

When did DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ Contrast Reduction System receive FDA 510(k) clearance?

DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ Contrast Reduction System received FDA 510(k) clearance on 2019-10-17, under 510(k) number K190102.

Who is the listed applicant for DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ Contrast Reduction System?

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

What is the FDA product code for DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ Contrast Reduction System?

The FDA product code for DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ Contrast Reduction System is DXT.

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Otros registros que enlistan a Osprey Medical, Inc. como solicitante

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Dispositivos relacionados (Código: DXT)

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Fuente oficial

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

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