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

    SAFE-CONNECT DRUG DISPENSING SPIKE, MODELS SC 4020, SC 4015, SC 4010, SC 4005

    K Number: K031783 · Decision Jul 1, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    2
    Review Days
    21

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    Basic Information

    Device Name
    SAFE-CONNECT DRUG DISPENSING SPIKE, MODELS SC 4020, SC 4015, SC 4010, SC 4005
    K Number
    K031783
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Intravascular Incorporated
    Date Received
    June 10, 2003
    Decision Date
    July 1, 2003
    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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