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    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter

    K Number: K160941 · Decision Dec 13, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    402
    Applicant Total
    8
    Review Days
    253

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    Basic Information

    Device Name
    Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter
    K Number
    K160941
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Brosmed Medical Co., Ltd.
    Date Received
    April 4, 2016
    Decision Date
    December 13, 2016
    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 Brosmed Medical Co., Ltd.

    K Number Device Name
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    K230705 POT PTCA Balloon Dilatation Catheter
    K212215 Tiche PTA Balloon Dilatation Catheter
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