BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    Chameleon PTA Balloon Catheter

    K Number: K170635 · Decision Mar 30, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    402
    Applicant Total
    3
    Review Days
    28

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    Basic Information

    Device Name
    Chameleon PTA Balloon Catheter
    K Number
    K170635
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Av Medical Technologies, Ltd.
    Date Received
    March 2, 2017
    Decision Date
    March 30, 2017
    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 Av Medical Technologies, Ltd.

    K Number Device Name
    K163231 Chameleon PTA Balloon Catheter
    K151678 Chameleon PTA Balloon Catheter