FDA 510(k)

DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System

K-Number: K171217 · 2017-05-26

Decision Date2017-05-26

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

DyeVert Plus Contrast Reduction System, DyeVert NG 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 2017-05-26 under 510(k) number K171217. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System?

DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System is a medical device that received FDA 510(k) clearance on 2017-05-26. The listed applicant is Osprey Medical, Inc.. The 510(k) number is K171217.

When did DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System receive FDA 510(k) clearance?

DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System received FDA 510(k) clearance on 2017-05-26, under 510(k) number K171217.

Who is the listed applicant for DyeVert Plus Contrast Reduction System, DyeVert NG 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, DyeVert NG Contrast Reduction System?

The FDA product code for DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System is DXT.

Other records listing Osprey Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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 K181936DyeVert PLUS EZ Contrast Reduction System K171698Smart Syringe K163054DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System K161505DyeVert NG Contrast Modulation System

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.