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FDA 510(k)

DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System

K-Number: K163054 · 2017-03-08

ApplicantOsprey Medical, Inc.
Decision Date2017-03-08
Product CodeDXT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System is a medical device manufactured by Osprey Medical, Inc.. It received FDA 510(k) clearance on 2017-03-08 under approval number K163054. 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 Modulation/Monitoring System, Contrast Monitoring System?

DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System is a medical device that received FDA 510(k) clearance on 2017-03-08. It is manufactured by Osprey Medical, Inc.. The 510(k) number is K163054.

When was DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System approved by the FDA?

DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System received FDA 510(k) clearance on 2017-03-08, under approval number K163054.

What company makes DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System?

DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System is manufactured by Osprey Medical, Inc..

What is the FDA product code for DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System?

The FDA product code for DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring 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 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

View all 8 devices →

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. K161505DyeVert NG Contrast Modulation SystemOsprey Medical, Inc. K160107DiamondTOUCH Inflation Device and Fluid Dispensing SyringeMerit Medical Systems, Inc. K152978DeRoyal Angiography KitsDeroyal Industries, 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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