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

    OTW Takeru PTCA Balloon Dilatation Catheter

    K Number: K172264 · Decision Mar 19, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    76
    Registration Numbers
    76
    Same Product Code
    85
    Applicant Total
    10
    Review Days
    235

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    Basic Information

    Device Name
    OTW Takeru PTCA Balloon Dilatation Catheter
    K Number
    K172264
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.5100
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    KANEKA Corporation
    Date Received
    July 27, 2017
    Decision Date
    March 19, 2018
    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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