BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

    BANTAM CATHETER (280MM BALLOON LENGTHS)

    K Number: K112335 · Decision Oct 12, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    277
    Same Product Code
    889
    Applicant Total
    7
    Review Days
    61

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    Basic Information

    Device Name
    BANTAM CATHETER (280MM BALLOON LENGTHS)
    K Number
    K112335
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ClearStream Technologies , Ltd.
    Date Received
    August 12, 2011
    Decision Date
    October 12, 2011
    Product Code
    DQY
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DQY Catheter, Percutaneous

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    Other Clearances by ClearStream Technologies , Ltd.

    K Number Device Name
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    K093139 BANTAM,48XXXXXX, 50XXXXXX
    K083596 REEKROSS FAMILY OR OTW PTA CATHETERS
    K072947 SAVVY LONG AND SLEEK PERIPHERAL TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS