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510(k) Data Aggregation

    K Number
    K062241
    Device Name
    ADJUSTABLE MULTI-CATHETER SOURCE APPLICTOR
    Manufacturer
    NORTH AMERICAN SCIENTIFIC, INC.
    Date Cleared
    2006-11-09

    (99 days)

    Product Code
    JAQ
    Regulation Number
    892.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORTH AMERICAN SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Adjustable Multi-Catheter Source Applicator is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy of breast cancer.
    Device Description
    Not Found
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    K Number
    K060679
    Device Name
    SURTRAK IMPLANTATION KIT
    Manufacturer
    NORTH AMERICAN SCIENTIFIC, INC.
    Date Cleared
    2006-04-21

    (37 days)

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

    NORTH AMERICAN SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The North American Scientific, Inc Brachytherapy Preloaded Needle Kit is indicated for interstitial implantation of select localized tumors with low to medium radiosensitivity. They are used either as primary treatment for tumors such as those in the head, neck, lung, pancreas, breast, cervix and prostate and unresectable turnors or for residual disease after excision of the primary turnor. North American Scientific Brachytherapy Preloaded Needle Kit implants are indicated for use with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy.
    Device Description
    Not Found
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    K Number
    K052024
    Device Name
    NSTRAND IMPLANTATION KIT
    Manufacturer
    NORTH AMERICAN SCIENTIFIC, INC.
    Date Cleared
    2005-09-07

    (43 days)

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

    NORTH AMERICAN SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The North American Scientific, Inc Brachytherapy Preloaded Needle Kit is indicated for interstitial implantation of select localized tumors with low to medium radiosensitivity. They are used primarily for treatment for tumors such as those in the head, neck, lung, pancreas, breast, cervix and prostate and unresectable tumors or for residual disease after excision of the primary tumor. Preloaded implants are used with or at the completion of other treatment modalities such as external beam radiation therapy or chemotherapy.
    Device Description
    Not Found
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    K Number
    K964647
    Device Name
    NORTH AMERICAN SCIENTIFIC (NASI) 1-125 RADIONUCLIDE BRACHYTHERAPY SOURCE
    Manufacturer
    NORTH AMERICAN SCIENTIFIC, INC.
    Date Cleared
    1997-02-10

    (82 days)

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

    NORTH AMERICAN SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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