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

    NEUROVASX SUB-MICROINFUSION CATHETER

    K Number: K984258 · Decision Feb 11, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    2
    Review Days
    73

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    Basic Information

    Device Name
    NEUROVASX SUB-MICROINFUSION CATHETER
    K Number
    K984258
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neuro Vasx, Inc.
    Date Received
    November 30, 1998
    Decision Date
    February 11, 1999
    Product Code
    DQO
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DQO Catheter, Intravascular, Diagnostic

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    Other Clearances by Neuro Vasx, Inc.

    K Number Device Name
    K011646 NEUROEDGE INFUSION CATHETER