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

    Chameleon PTA Balloon Catheter

    K Number: K151678 · Decision Sep 21, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    402
    Applicant Total
    3
    Review Days
    91

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    Basic Information

    Device Name
    Chameleon PTA Balloon Catheter
    K Number
    K151678
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Av Medical Technologies, Ltd.
    Date Received
    June 22, 2015
    Decision Date
    September 21, 2015
    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
    K170635 Chameleon PTA Balloon Catheter
    K163231 Chameleon PTA Balloon Catheter