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510(k) Data Aggregation

    K Number
    K140490
    Device Name
    CIVA SHEET PD-103
    Date Cleared
    2014-08-29

    (183 days)

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

    CIVATECH ONCOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    CivaSheet is indicated for use as a permanent interstitial brachytherapy source for the treatment of selected localized tumors. The device may be used either as the primary treatment or for treatment of residual disease after excision of the primary tumor. CivaSheet may be indicated for use concurrently with or sequentially with other treatment modalities, such as external beam radiation therapy or chemotherapy.
    Device Description
    The CivaSheet is a planar brachytherapy device designed to be implanted in the body to treat selected localized tumors. The CivaSheet utilizes biocompatible materials to encapsulate Pd-103, a radionuclide with a long history in radiotherapy. CivaSheet will be offered in two configurations: a shielded unidirectional version, and an unshielded version. Both versions are intended as permanent implants and are partially bio-absorbable.
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    K Number
    K082159
    Device Name
    CIVASTRING PD-103
    Date Cleared
    2008-09-30

    (61 days)

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

    CIVATECH ONCOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    CivaStringPd103 is intended for medical purposes to be placed into a body cavity or tissue as a source of nuclear radiation for therapy. CivaStringPd103 is indicated for use as a permanent interstitial brachytherapy source for the treatment of selected localized tumors. The device may be used either as the primary treatment or for treatment of residual disease after excision of the primary tumor. CivaString 4103 may be indicated for use concurrently with or sequentially with other treatment modalities, such as external beam radiation therapy or chemotherapy.
    Device Description
    CivaString" d103 is a linear LDR (low dose rate) brachytherapy source comprised of polymeric materials. CivaString 1103 contains Pd-103 isotope that is distributed into "wells" along the length of the device. Wells may be filled or left empty (to provide gaps in regions where no radiation is desired) based on the overall therapy plan prescription.
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