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510(k) Data Aggregation

    K Number
    K973328
    Device Name
    INTERSOURCE
    Manufacturer
    INTERNATIONAL BRACHYTHERAPY, SA
    Date Cleared
    1998-12-10

    (462 days)

    Product Code
    KXK
    Regulation Number
    892.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERNATIONAL BRACHYTHERAPY, SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    InterSeed™ implants are indicated for interstitial implantation of select localized tumors with low to moderate radiosensitivity. They are used either as primary treatment for tumors such as those of the head, lung, neck, pancreas, prostate, and unresectable tumors, or for residual disease after excision of the primary tumor. InterSeed™ implants are indicated for use concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy.
    Device Description
    InterSeed™ is an hermetically sealed radiotherapeutic source indicated for interstitial implantation. The radionuclide used in InterSeed™ is Palladium 103 (Pd-103). InterSeed™ is constructed by placing a platinum radiopaque marker and Pd-103 on the surface of a medical grade titanium inner tube. The device is sealed by sliding an outer tube, also medical grade titanium, over the inner tube and laser welding both ends. The resulting device has a hollow center with an inner diameter of 0.35 mm with all body tissue contacting surfaces made from medical grade titanium.
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