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510(k) Data Aggregation

    K Number
    K041929
    Device Name
    MAMMOSITE II RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY
    Manufacturer
    PROXIMA THERAPEUTICS, INC.
    Date Cleared
    2004-08-26

    (38 days)

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

    PROXIMA THERAPEUTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MammoSite RTS is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer.
    Device Description
    The MammoSite is a radiation therapy system that includes the MammoSite Catheter Tray and the MammoSite HDR Afterloader Accessories Tray. The MammoSite Catheter Tray includes the MammoSite catheter and accessories to assist with the implantation of the catheter. The MammoSite is a catheter shaft with an inflatable balloon mounted on its distal end that positions the radiation source within the resected cavity for radiation delivery. The MammoSite Afterloader Accessories Tray contains the items needed to connect the afterloader to the MammoSite.
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    K Number
    K032067
    Device Name
    MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY
    Manufacturer
    PROXIMA THERAPEUTICS, INC.
    Date Cleared
    2004-02-10

    (222 days)

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

    PROXIMA THERAPEUTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MammoSite RTS is an applicator intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer.
    Device Description
    The MammoSite RTS is a radiation therapy system that includes the MammoSite RTS Catheter Tray and the MammoSite HDR Afterloader Accessories Tray. The MammoSite RTS Catheter Tray includes the MammoSite catheter and accessories to assist with the implantation of the catheter. The MammoSite is a catheter shaft with an inflatable balloon mounted on its distal end that positions the radiation source within the resected cavity for radiation delivery. The MammoSite Afterloader Accessories Tray contains the items needed to connect the afterloader to the MammoSite. Any device specifications that have changed as a result of the modifications to the device presented in this 510(k) have been documented in Proxima's product specifications for the MammoSite RTS.
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    K Number
    K030558
    Device Name
    MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY
    Manufacturer
    PROXIMA THERAPEUTICS, INC.
    Date Cleared
    2003-05-21

    (89 days)

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

    PROXIMA THERAPEUTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MammoSite is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer.
    Device Description
    The MammoSite RTS is a radiation therapy system that includes the MammoSite RTS Catheter Tray and the MammoSite HDR Afterloader Accessories Tray. The MammoSite RTS Catheter Tray includes the MammoSite catheter and accessories to assist with the implantation of the catheter. The MammoSite is a catheter shaft with an inflatable balloon mounted on its distal end that positions the radiation source within the resected cavity for radiation delivery. The MammoSite Afterloader Accessories Tray contains the items needed to connect the afterloader to the MammoSite. Any device specifications that have changed as a result of the modifications to the device presented in this 510(k) have been documented in Proxima's product specifications for the MammoSite RTS.
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    K Number
    K011690
    Device Name
    MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY
    Manufacturer
    PROXIMA THERAPEUTICS, INC.
    Date Cleared
    2002-05-06

    (340 days)

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

    PROXIMA THERAPEUTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MammoSite Radiation Therapy System is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer.
    Device Description
    The MammoSite™ RTS is a radiation therapy system that includes the MammoSite RTS Catheter Tray and the MammoSite HDR Afterloader Accessories Tray. The MammoSite RTS Catheter Tray includes the MammoSite catheter and accessories to assist with the implantation of the catheter. The MammoSite catheter is a shaft with an inflatable balloon that positions the radiation source within the resected cavity for radiation delivery. The MammoSite is a variable 4 cm - 5 cm spherically inflated balloon. The MammoSite Afterloader Accessories Tray contains the items needed to connect the afterloader to the MammoSite RTS.
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    K Number
    K003206
    Device Name
    GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005
    Manufacturer
    PROXIMA THERAPEUTICS, INC.
    Date Cleared
    2001-04-25

    (194 days)

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

    PROXIMA THERAPEUTICS, INC.

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

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