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FDA 510(k)

DyeVert PLUS EZ Contrast Reduction System

N.º K: K181936 · 2018-10-25

SolicitanteOsprey Medical, Inc.
Fecha de decisión2018-10-25
Código de productoDXT
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

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 2018-10-25 under 510(k) number K181936. 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 EZ Contrast Reduction System?

DyeVert PLUS EZ Contrast Reduction System is a medical device that received FDA 510(k) clearance on 2018-10-25. The listed applicant is Osprey Medical, Inc.. The 510(k) number is K181936.

When did DyeVert PLUS EZ Contrast Reduction System receive FDA 510(k) clearance?

DyeVert PLUS EZ Contrast Reduction System received FDA 510(k) clearance on 2018-10-25, under 510(k) number K181936.

Who is the listed applicant for 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 EZ Contrast Reduction System?

The FDA product code for DyeVert PLUS EZ Contrast Reduction System is DXT.

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Otros registros que enlistan a Osprey Medical, Inc. 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.

K190102DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ Contrast Reduction SystemK183267DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction System, DyeTect™ Contrast Monitoring Disposable Kit, Smart Syringe, DyeVert™ PLUS EZ Contrast Reduction SystemK171698Smart SyringeK171217DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction SystemK163054DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring SystemK161505DyeVert NG Contrast Modulation System

Ver todos los 8 dispositivos →

Dispositivos relacionados (Código: DXT)

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.

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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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