FDA 510(k)

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

K-Number: K190102 · 2019-10-17

Decision Date2019-10-17

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

DyeVert Plus Contrast Reduction System, DyeTect Contrast Monitoring System, DyeVert Plus EZ Contrast Reduction System is a medical device manufactured by Osprey Medical, Inc.. It received FDA 510(k) clearance on 2019-10-17 under approval number K190102. 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, 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. It is manufactured by Osprey Medical, Inc.. The 510(k) number is K190102.

When was DyeVert Plus Contrast Reduction System, DyeTect Contrast Monitoring System, DyeVert Plus EZ Contrast Reduction System approved by the FDA?

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 approval number K190102.

What company makes 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 manufactured by Osprey Medical, Inc..

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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Other Devices by Osprey Medical, Inc.

K161505DyeVert NG Contrast Modulation System K153141DyeVert Contrast Modulation System K171698Smart Syringe K171217DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System K163054DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring 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

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Related Devices (Code: DXT)

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Official Source

View on FDA Database →

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