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

    SLEEK OTW PTA CATHETERS

    K Number: K102035 · Decision Dec 1, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    402
    Applicant Total
    7
    Review Days
    135

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    Basic Information

    Device Name
    SLEEK OTW PTA CATHETERS
    K Number
    K102035
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ClearStream Technologies , Ltd.
    Date Received
    July 19, 2010
    Decision Date
    December 1, 2010
    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 ClearStream Technologies , Ltd.

    K Number Device Name
    K112335 BANTAM CATHETER (280MM BALLOON LENGTHS)
    K101361 REEFLEX PTA CATHETER
    K100490 LITEPAC, MODEL 682
    K093139 BANTAM,48XXXXXX, 50XXXXXX
    K083596 REEKROSS FAMILY OR OTW PTA CATHETERS
    K072947 SAVVY LONG AND SLEEK PERIPHERAL TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS