FDA 510(k)

DyeVert PLUS EZ Contrast Reduction System

Numéro K : K181936 · 2018-10-25

Date de décision2018-10-25

Code produitDXT

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Autres dossiers indiquant Osprey Medical, Inc. en tant que demandeur

K190102DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ Contrast Reduction System K183267DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction System, DyeTect™ Contrast Monitoring Disposable Kit, Smart Syringe, DyeVert™ PLUS EZ Contrast Reduction System K171698Smart Syringe K171217DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System K163054DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System K161505DyeVert NG Contrast Modulation System

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Dispositifs connexes (Code : DXT)

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Source officielle

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