Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K001366
    Device Name
    PROSTEC 125I BRANCHYTHERAPY SNAPSEED
    Manufacturer
    Date Cleared
    2000-09-19

    (172 days)

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

    PROSTEC LLC.

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

    Ask a specific question about this device

    K Number
    K993280
    Device Name
    PROSTEC 125I BRACHYTHERAPY SEEDS
    Manufacturer
    Date Cleared
    2000-03-14

    (166 days)

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

    PROSTEC LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    125I Brachytherapy Seeds are intended for permanent interstitial implantation in selected localized tumors. The devices are implanted as a source of nuclear radiation for therapy.
    Device Description
    The 125I Brachytherapy Seeds consist of 125I absorbed onto the surface of a spherical polymeric substrate sealed in a welded titanium casing. A typical Brachytherapy Seed is shown below. For higher activity levels the number of beads with absorbed 1431 may be increased from 2 to 4. Typically, the 1351 Brachytherapy Seeds are placed within or in close to the turnor to be treated utilizing guidance. The devices are delivered using an 18 gauge or greater diameter hypodermic needle.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1