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510(k) Data Aggregation

    K Number
    K030594
    Device Name
    I-125 RAPID STRAND, MODEL 7000
    Manufacturer
    AMERSHAM HEALTH
    Date Cleared
    2003-04-10

    (44 days)

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

    AMERSHAM HEALTH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    RAPID Strand ™ is indicated for permanent interstitial implantation of selected localized tumors which are low to moderate radiosensitivity. They may be used either as primary treatment (such as prostate cancer or unresectable tumors) or for treatment of residual disease after excision of the primary tumor. RAPID Strand™ may be indicated for use concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy.
    Device Description
    RAPID Strand™ consists of 11 absorbable seeding spacers and 10 Model 6711 OncoSeed™ seeds (welded titanium capsule containing I-125 adsorbed onto a silver rod) spaced at a fixed distance within absorbable braided carrier. The absorbable braided carrier containing OncoSeeds and absorbable seeding spacer is stiffened and then sterilized by Ethylene Oxide. The seeds are housed in a plastic spacing jig within a stainless steel shielding tube which attenuates >99% of the I-125 photons. RAPID Strand™ is STERILE when shipped. The Customized RAPID Strand allows the variable seed spacing to reflect individual patient prescriptions as specified by the treating physician. This Customized RAPID Strand will have less than ten (10) OncoSeed™ seeds and a variable number of Absorbable Seeding Spacers. The treating physician will determine the required dose and total number of active seeds for each Customized RAPID Strand.
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