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

    FOCUS PC BALLOON DILATATION CATHETER

    K Number: K954313 · Decision Dec 1, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    402
    Applicant Total
    4
    Review Days
    77

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    Basic Information

    Device Name
    FOCUS PC BALLOON DILATATION CATHETER
    K Number
    K954313
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardio-Dynamics, Inc.
    Date Received
    September 15, 1995
    Decision Date
    December 1, 1995
    Product Code
    LIT
    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
    LIT Catheter, Angioplasty, Peripheral, Transluminal

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    Other Clearances by Cardio-Dynamics, Inc.

    K Number Device Name
    K945943 CVD PERIFLOW(TM) BALLOON DILATATION CATHETER
    K942150 CVD SMALL VESSEL BALLOON DILATION CATHETER
    K931027 BULLETT PERIPHERAL INFUSION CATHETER