Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DyeVert PLUS EZ Contrast Reduction System

K-Number: K181936 · 2018-10-25

ApplicantOsprey Medical, Inc.
Decision Date2018-10-25
Product CodeDXT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DyeVert PLUS EZ Contrast Reduction System is a medical device manufactured by Osprey Medical, Inc.. It received FDA 510(k) clearance on 2018-10-25 under approval number K181936. 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 EZ Contrast Reduction System?

DyeVert PLUS EZ Contrast Reduction System is a medical device that received FDA 510(k) clearance on 2018-10-25. It is manufactured by Osprey Medical, Inc.. The 510(k) number is K181936.

When was DyeVert PLUS EZ Contrast Reduction System approved by the FDA?

DyeVert PLUS EZ Contrast Reduction System received FDA 510(k) clearance on 2018-10-25, under approval number K181936.

What company makes DyeVert PLUS EZ Contrast Reduction System?

DyeVert PLUS EZ Contrast Reduction System is manufactured by Osprey Medical, Inc..

What is the FDA product code for DyeVert PLUS EZ Contrast Reduction System?

The FDA product code for DyeVert PLUS EZ Contrast Reduction System is DXT.

Related Clinical Trials

NCT07475091 Standardizing Swallow Pressure Measurements NOT_YET_RECRUITING NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT07608614 Sleep and Performance RECRUITING NCT07601503 Evaluating In-line Chlorination in Nigeria NOT_YET_RECRUITING NCT07221565 Electromagnetic Immunotherapy Mapping and Cytokine Forecasting Study (QSIT) ENROLLING_BY_INVITATION NCT06414265 Reduction of Mitral Regurgitation With the SATURN Trans-Septal Transcatheter Mitral Valve Replacement (TMVR) System in Patients With Severe Symptomatic Mitral Regurgitation RECRUITING

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

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.

↑