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510(k) Data Aggregation

    K Number
    K213915
    Device Name
    BIB Stent Placement Catheter
    Manufacturer
    NuMED Inc.
    Date Cleared
    2022-01-12

    (28 days)

    Product Code
    NVM
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    NuMED Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated for CP Stent / Covered CP Stent and G-Armor Covered Stent placement in vessels over 8mm in diameter
    Device Description
    Not Found
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