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FDA 510(k)

DyeVert NG Contrast Modulation System

K-Number: K161505 · 2016-08-03

ApplicantOsprey Medical, Inc.
Decision Date2016-08-03
Product CodeDXT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DyeVert NG Contrast Modulation 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 2016-08-03 under 510(k) number K161505. 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 NG Contrast Modulation System?

DyeVert NG Contrast Modulation System is a medical device that received FDA 510(k) clearance on 2016-08-03. The listed applicant is Osprey Medical, Inc.. The 510(k) number is K161505.

When did DyeVert NG Contrast Modulation System receive FDA 510(k) clearance?

DyeVert NG Contrast Modulation System received FDA 510(k) clearance on 2016-08-03, under 510(k) number K161505.

Who is the listed applicant for DyeVert NG Contrast Modulation 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 NG Contrast Modulation System?

The FDA product code for DyeVert NG Contrast Modulation 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 SystemK183267DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction System, DyeTect™ Contrast Monitoring Disposable Kit, Smart Syringe, DyeVert™ PLUS EZ Contrast Reduction SystemK181936DyeVert PLUS EZ Contrast Reduction SystemK171698Smart SyringeK171217DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction SystemK163054DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System

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Related Devices (Code: DXT)

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.

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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.

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