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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 a medical device manufactured by Osprey Medical, Inc.. It received FDA 510(k) clearance on 2016-08-03 under approval 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. It is manufactured by Osprey Medical, Inc.. The 510(k) number is K161505.

When was DyeVert NG Contrast Modulation System approved by the FDA?

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

What company makes DyeVert NG Contrast Modulation System?

DyeVert NG Contrast Modulation System is manufactured by Osprey Medical, Inc..

What is the FDA product code for DyeVert NG Contrast Modulation System?

The FDA product code for DyeVert NG Contrast Modulation System is DXT.

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Other Devices by Osprey Medical, Inc.

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 K181936DyeVert PLUS EZ Contrast Reduction System

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Related Devices (Code: DXT)

K152906Disposable High Pressure Injector SyringeWuxi Yushou Medical Appliances Co., Ltd. K160190Sunmed Control SyringesSunny Medical Device (Shenzhen) Co., Ltd. K161471MR Syringe Dual Pack for Solaris InjectorsCoeur, Inc. K160107DiamondTOUCH Inflation Device and Fluid Dispensing SyringeMerit Medical Systems, Inc. K152978DeRoyal Angiography KitsDeroyal Industries, Inc. K153141DyeVert Contrast Modulation SystemOsprey Medical, Inc.

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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