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

    IVAS 20MM (10 GAUGE) BALLOON CATHETER

    K Number: K113477 · Decision Jan 6, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    107
    Applicant Total
    6
    Review Days
    44

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    Basic Information

    Device Name
    IVAS 20MM (10 GAUGE) BALLOON CATHETER
    K Number
    K113477
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3027
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stryker Instruments, Instruments Div.
    Date Received
    November 23, 2011
    Decision Date
    January 6, 2012
    Product Code
    NDN
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NDN Cement, Bone, Vertebroplasty

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    Other Clearances by Stryker Instruments, Instruments Div.

    K Number Device Name
    K123178 STRYKER VENOM ELECTRODES AND CANNULAE
    K093419 IVAS 2-10MM (10 GAUGE) BALLOON CATHETER, IVAS 2-15 MM(10 GAUGE)0705-115-500, IVAS 3-10MM(8 GAUGE)BALLOON CATHETER, IVAS
    K072702 STRYKER ANTIMIC CATHETER
    K073017 STRYKER STRI-SHIELD FLYTE TOGAS
    K070078 STRYKER T4 HYTREL TOGA