BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ELM PTA BALLON DILATATION CATHETER

    K Number: K113468 · Decision Dec 20, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    94
    Registration Numbers
    94
    Same Product Code
    399
    Applicant Total
    2
    Review Days
    28

    Basic Information

    Device Name
    ELM PTA BALLON DILATATION CATHETER
    K Number
    K113468
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CREAGH MEDICAL LTD
    Date Received
    November 22, 2011
    Decision Date
    December 20, 2011
    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 CREAGH MEDICAL LTD

    K Number Device Name
    K102645 WILLOW/ELM PTA BALLOON DILATATION CATHETER