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

    SWABSITE SWABBABLE VALVE, MODEL 245000

    K Number: K002689 · Decision Mar 6, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    437
    Registration Numbers
    437
    Same Product Code
    1167
    Applicant Total
    31
    Review Days
    189

    Basic Information

    Device Name
    SWABSITE SWABBABLE VALVE, MODEL 245000
    K Number
    K002689
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    QUEST MEDICAL, INC.
    Date Received
    August 29, 2000
    Decision Date
    March 6, 2001
    Product Code
    FPA
    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
    FPA Set, Administration, Intravascular

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