BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

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

    K Number: K190102 · Decision Oct 17, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    209
    Applicant Total
    14
    Review Days
    268

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    Basic Information

    Device Name
    DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ Contrast Reduction System
    K Number
    K190102
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Osprey Medical, Inc.
    Date Received
    January 22, 2019
    Decision Date
    October 17, 2019
    Product Code
    DXT
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DXT Injector And Syringe, Angiographic

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    Other Clearances by Osprey Medical, Inc.

    K Number Device Name
    K183267 DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction System, DyeTect™ Contrast Monitoring Disposable Kit, Smart Syringe, DyeVert™ PLUS EZ Contrast Reduction System
    K181936 DyeVert PLUS EZ Contrast Reduction System
    K171698 Smart Syringe
    K171217 DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System
    K163054 DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System
    K161505 DyeVert NG Contrast Modulation System
    K153141 DyeVert Contrast Modulation System
    K151300 AVERT Contrast Modulation System
    K151746 Dyevert Contrast Modulation System
    K150485 AVERT Contrast Modulation System
    Search all 14 clearances from Osprey Medical, Inc. →