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

    0.9% SODIUM CHLORIDE VASCULAT ACCESS DEVICE

    K Number: K000632 · Decision Oct 19, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    2
    Review Days
    238

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    Basic Information

    Device Name
    0.9% SODIUM CHLORIDE VASCULAT ACCESS DEVICE
    K Number
    K000632
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Avitro, LLC
    Date Received
    February 24, 2000
    Decision Date
    October 19, 2000
    Product Code
    FOZ
    Advisory Committee
    General Hospital
    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
    FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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    Other Clearances by Avitro, LLC

    K Number Device Name
    K001795 THE AVITRO LLC, 10 AND 100 USO UNITS/ML HEPARIN SODIUM VAFD