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

    OCCLUSION BALLON CATHETER MODIFICAION

    K Number: K921399 · Decision Sep 25, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    186
    Registration Numbers
    186
    Same Product Code
    203
    Applicant Total
    28
    Review Days
    185

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    Basic Information

    Device Name
    OCCLUSION BALLON CATHETER MODIFICAION
    K Number
    K921399
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Interventional Therapeutics Corp.
    Date Received
    March 24, 1992
    Decision Date
    September 25, 1992
    Product Code
    DXC
    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
    DXC Clamp, Vascular

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