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510(k) Data Aggregation

    K Number
    K041370
    Device Name
    LIFESTENT LP SDS BILIARY ENDOPROSTHESIS
    Manufacturer
    ORBUS MEDICAL TECHNOLOGIES
    Date Cleared
    2004-06-24

    (31 days)

    Product Code
    FGE
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORBUS MEDICAL TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Orbus LifeStent LP SDS Biliary Endoprosthesis is indicated for the palliation of malignant neoplasms in the biliary tree.
    Device Description
    The LifeStent LP SDS Biliary Endoprosthesis consists of a balloon expandable stent which is mounted onto a transluminal angioplasty (PTA) balloon catheter which acts as the delivery system. The permanently implanted device used to maintain patency of a lumen compromised by tissue of an impinging tumor. The flexible, balloon expandable stent is made by laser cutting an open lattice design into a 316L stainless steel tube. The stent is supplied mounted onto a PTA balloon catheter, inserted percutaneously to the diseased site, and expanded by balloon. The systems are available with an expanded diameter of 5.0 mm at stent lengths of 18, 36 and 56mm.
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    K Number
    K041032
    Device Name
    MODIFICATION TO LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS
    Manufacturer
    ORBUS MEDICAL TECHNOLOGIES
    Date Cleared
    2004-05-10

    (19 days)

    Product Code
    FGE
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORBUS MEDICAL TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Orbus LifeStent XL SDS Biliary Endoprosthesis is indicated for the palliation of malignant neoplasms in the biliary tree.
    Device Description
    The LifeStent XL SDS Biliary Endoprosthesis consists of a balloon expandable stent which is I ne Enehein AL SDD Dipercutaneous transluminal angioplasty (PTA) balloon catheter which acts as the delivery system. The stent is a permanently implanted device used to maintain patency of a major bile duct obstructed by tissue of an impinging tumor. The flexible, balloon expandable stent is made by laser cutting an open lattice design into a 316L stainless steel tube. The stent is supplied mounted onto a PTA balloon catheter, inserted percutaneously to the diseased site, and expanded by balloon inflation. The systems are available with expanded diameter of 100mm at stent lengths of 17, 27, 37mm.
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    K Number
    K040550
    Device Name
    LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS
    Manufacturer
    ORBUS MEDICAL TECHNOLOGIES
    Date Cleared
    2004-03-16

    (14 days)

    Product Code
    FGE
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORBUS MEDICAL TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Orbus LifeStent XL SDS Biliary Endoprosthesis is indicated for the palliation of malignant neoplasms in the biliary tree.
    Device Description
    The LifeStent XL SDS Biliary Endoprosthesis consists of a balloon expandable stent which is provided mounted onto a percutaneous transluminal angioplasty (PTA) balloon catheter that acts as the delivery system. The stent is a permanently implanted device used to maintain patency of a major bile duct obstructed by tissue of an impinging tumor. The flexible, balloon expandable stent is made by laser cutting an open lattice design into a 316L stainless steel tube. The stent is inserted percutaneously to the diseased site, and supplied mounted onto a PTA balloon catheter, available with expanded diameters of 8.0 and 9.0mm at stent lengths of 17, 27, 37mm.
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    K Number
    K033212
    Device Name
    LIFESTENT SDS BILIARY ENDOPROSTHESIS
    Manufacturer
    ORBUS MEDICAL TECHNOLOGIES
    Date Cleared
    2003-10-30

    (27 days)

    Product Code
    FGE
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORBUS MEDICAL TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Orbus LifeStent SDS Biliary Endoprosthesis is indicated for the palliation of malignant neoplasms in the biliary tree.
    Device Description
    The LifeStent SDS Biliary Endoprosthesis consists of a balloon expandable stent which is provided mounted onto a percutaneous transluminal angioplasty (PTA) balloon catheter which acts as the delivery system. The stent is a permanently implanted device used to maintain patency of a major bile duct obstructed by tissue of an impinging tumor. The flexible, balloon expandable stent is made by laser cutting an open lattice design into a 316L stainless steel tube. The stent is supplied mounted onto a PTA balloon catheter, inserted percutaneously to the diseased site, and expanded by balloon inflation. The systems are available with an expanded diameter of 8.0 mm at stent lengths of 18 mm.
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    K Number
    K023308
    Device Name
    LIFESTENT SDS BILIARY ENDOPROSTHESIS, LIFESTENT XL SDS BILIARY ENDOPROSTHESIS
    Manufacturer
    ORBUS MEDICAL TECHNOLOGIES
    Date Cleared
    2003-04-14

    (193 days)

    Product Code
    FGE
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORBUS MEDICAL TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Orbus LifeStent SDS Biliary Endoprosthesis is indicated for use in the palliation of malignant neoplasms in the biliary tree.
    Device Description
    The LifeStent SDS Biliary Endoprosthesis consists of a balloon expandable stent which is provided mounted onto a percutaneous transluminal angioplasty (PTA) balloon catheter which acts as the delivery system. The stent is a permanently implanted device used to maintain patency of a major bile duct obstructed by tissue of an impinging tumor. The flexible, balloon expandable stent is made by laser cutting an open lattice design into a 316L stainless steel tube. The stent is supplied mounted onto a PTA balloon catheter, inserted percutaneously to the diseased site, and expanded by balloon inflation. The systems are available with expanded diameters of 6.0, 7.0, and 8.0 mm at stent lengths of 18, 26, 36, and 56 mm.
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    K Number
    K023121
    Device Name
    LIFESTENT BILIARY ENDOPROSTHESIS
    Manufacturer
    ORBUS MEDICAL TECHNOLOGIES
    Date Cleared
    2003-03-10

    (172 days)

    Product Code
    FGE
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORBUS MEDICAL TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LifeStent Biliary Endoprosthesis is intended for the palliation of malignant neoplasms in the biliary tree.
    Device Description
    The LifeStent Biliary Endoprosthesis is a permanently implanted device used to maintain patency of a major bile duct obstructed by tissue of an impinging tumor. The device is a balloon expandable stent made by laser cutting an open lattice design into a 316L stainless steel tube. The stent is designed to be manually crimped onto a PTA balloon catheter, inserted percutaneously to the diseased site, and deployed by balloon inflation. The stents are available with an expansion range of 4.0-7.0 mm at lengths of 13, 18, 26, 36, and 56 mm.
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    K Number
    K023248
    Device Name
    LIFESTENT LP SDS BILIARY ENDOPROSTHESIS
    Manufacturer
    ORBUS MEDICAL TECHNOLOGIES
    Date Cleared
    2003-02-11

    (134 days)

    Product Code
    FGE
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORBUS MEDICAL TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Orbus LifeStent LP SDS Biliary Endoprosthesis is indicated for use for the palliation of malignant neoplasms in the biliary tree.
    Device Description
    The LifeStent LP SDS Biliary Endoprosthesis consists of a balloon expandable stent which is provided mounted onto a percutaneous transluminal angioplasty (PTA) balloon catheter which acts as the delivery system. The stent is a permanently implanted device used to maintain patency of a major bile duct obstructed by tissue of an impinging tumor. This flexible, balloon expandable stent is made by laser cutting an open lattice design into a 316L stainless steel tube. The stent is supplied mounted onto a PTA balloon catheter, inserted percutaneously to the diseased site, and expanded by balloon inflation. The systems are available with expanded diameters of 4.0, 5.0, 6.0 mm at stent lengths of 18, 36, and 56 mm.
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    K Number
    K010107
    Device Name
    R STENT BILIARY ENDOPROSTHESIS
    Manufacturer
    ORBUS MEDICAL TECHNOLOGIES
    Date Cleared
    2001-07-31

    (200 days)

    Product Code
    FGE
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORBUS MEDICAL TECHNOLOGIES

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

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