BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    RX NC Takeru PTCA Balloon Dilatation Catheter

    K Number: K170941 · Decision Jul 7, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    76
    Registration Numbers
    76
    Same Product Code
    85
    Applicant Total
    10
    Review Days
    99

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    Basic Information

    Device Name
    RX NC Takeru PTCA Balloon Dilatation Catheter
    K Number
    K170941
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5100
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    KANEKA Corporation
    Date Received
    March 30, 2017
    Decision Date
    July 7, 2017
    Product Code
    LOX
    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
    LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous

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    Other Clearances by KANEKA Corporation

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