Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K981809
    Device Name
    CAROLINE GUIDE
    Date Cleared
    1998-08-14

    (85 days)

    Product Code
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    SURGICAL SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Caroline Guide is intended for use by neurosurgeons during posterior ventricular catheter placement procedures. Statement of indications for use: The Caroline Guide is indicated for use by neurosurgeons for posterior ventricular catheter placement for patients who are: 1) Adults or children 2) Have enlarged ventricles 3) Have no intracranial mass legions or any structural abnormalities other than hydrocephalus 4) Have no general contraindications to surgery
    Device Description
    The Caroline Guide is a mechanical device that helps the surgeon orient a ventricular catheter along a straight line connecting the posterior burr hole entrance point and a frontal target point.
    Ask a Question

    Ask a specific question about this device

    K Number
    K973277
    Device Name
    CAROLINE GUIDE/DELIA LOCALIZER
    Date Cleared
    1997-11-17

    (76 days)

    Product Code
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    SURGICAL SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Delia Localizer and Caroline Guide are indicated for use by neurosurgeons as shunt accessories for patients scheduled to undergo a posterior ventricular catheter placement procedure who are: 1) Adults 2) Have enlarged ventricles 3) Have normal scalp, skull, external ear and orbital anatomy 4) Do not have intracranial mass lesions or any structural abnormalities other than hydrocephalus 5) Have no general contraindications to surgery
    Device Description
    The Delia Localizer is a head-band based apparatus that aids the surgeon in identifying the optimal location for placing a posterior burr hole for purposes of inserting a posterior ventricular catheter. It mechanically reduces to practice geometric principles that are already used to manually calculate where to position a posterior burr hole. The Caroline Guide is a mechanical device that helps the surgeon orient a ventricular catheter along a straight line connecting the posterior burr hole entrance point and the frontal target point.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1