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510(k) Data Aggregation
K Number
K041370Device Name
LIFESTENT LP SDS BILIARY ENDOPROSTHESIS
Manufacturer
ORBUS MEDICAL TECHNOLOGIES
Date Cleared
2004-06-24
(31 days)
Product Code
FGE
Regulation Number
876.5010Why 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
K041032Device 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
876.5010Why 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
K040550Device Name
LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS
Manufacturer
ORBUS MEDICAL TECHNOLOGIES
Date Cleared
2004-03-16
(14 days)
Product Code
FGE
Regulation Number
876.5010Why 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
K033212Device Name
LIFESTENT SDS BILIARY ENDOPROSTHESIS
Manufacturer
ORBUS MEDICAL TECHNOLOGIES
Date Cleared
2003-10-30
(27 days)
Product Code
FGE
Regulation Number
876.5010Why 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
K023308Device 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
876.5010Why 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
K023121Device Name
LIFESTENT BILIARY ENDOPROSTHESIS
Manufacturer
ORBUS MEDICAL TECHNOLOGIES
Date Cleared
2003-03-10
(172 days)
Product Code
FGE
Regulation Number
876.5010Why 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
K023248Device Name
LIFESTENT LP SDS BILIARY ENDOPROSTHESIS
Manufacturer
ORBUS MEDICAL TECHNOLOGIES
Date Cleared
2003-02-11
(134 days)
Product Code
FGE
Regulation Number
876.5010Why 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
K010107Device Name
R STENT BILIARY ENDOPROSTHESIS
Manufacturer
ORBUS MEDICAL TECHNOLOGIES
Date Cleared
2001-07-31
(200 days)
Product Code
FGE
Regulation Number
876.5010Why did this record match?
Applicant Name (Manufacturer) :
ORBUS MEDICAL TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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