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510(k) Data Aggregation
K Number
K023243Device Name
MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
Manufacturer
SULZER INTRATHERAPEUTICS, INC.
Date Cleared
2002-12-13
(74 days)
Product Code
FGE
Regulation Number
876.5010Why did this record match?
Applicant Name (Manufacturer) :
SULZER INTRATHERAPEUTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology is intended as a palliative treatment of malignant neoplasms in the biliary tree.
Device Description
The Protége™ stent is a self-expanding nitinol (nickel-titanium alloy) stent provided in multiple lengths, (20 - 150 mm) and diameters (6 - 12 mm). The stent is electropolished. The stent is premounted on a 6 or 7 Fr delivery catheter over-the-wire delivery catheter designed for transhepatic access. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency in the biliary ducts. The disposable StarPort Delivery Technology system is comprised of an inner and outer sheath, which are locked together with a safety lock.
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K Number
K021729Device Name
MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
Manufacturer
SULZER INTRATHERAPEUTICS, INC.
Date Cleared
2002-06-21
(28 days)
Product Code
FGE
Regulation Number
876.5010Why did this record match?
Applicant Name (Manufacturer) :
SULZER INTRATHERAPEUTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology is intended as a palliative treatment of malignant neoplasms in the biliary tree.
Device Description
The Protégé™ stent is a self-expanding nitinol (nickel-titanium alloy) stent provided in multiple lengths, (20 - 80 mm) and diameters (6 - 12 mm). The stent is electropolished. The stent is premounted on an 80 or 120 cm working length, 0.035" over-the-wire delivery catheter designed for transhepatic access. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency in the biliary ducts. The disposable StarPort Delivery Technology system is comprised of an inner and outer sheath, which are locked together with a safety lock.
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K Number
K021563Device Name
INTRACOIL SELF-EXPANDING PERIPHERAL STENT
Manufacturer
SULZER INTRATHERAPEUTICS, INC.
Date Cleared
2002-05-31
(18 days)
Product Code
JCT
Regulation Number
878.3720Why did this record match?
Applicant Name (Manufacturer) :
SULZER INTRATHERAPEUTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IntraCoil® Peripheral Stent is indicated for use in the treatment of bronchial strictures produced by malignant neoplasms.
Device Description
The IntraCoil Stent is a self-expanding nickel-titanium (Nitinol) coil premounted on a delivery catheter. The stent is provided in diameters 4 to 8 mm, and lengths of 40 and 60 mm. The stent is indicated for use in the treatment of bronchial strictures produced by malignant neoplasms. Upon deployment the stent expands to conform to the bronchial lumen surface.
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K Number
K020528Device Name
INTRASTENT LD (LARGE DIAMETER) STENT
Manufacturer
SULZER INTRATHERAPEUTICS, INC.
Date Cleared
2002-04-16
(56 days)
Product Code
FGE
Regulation Number
876.5010Why did this record match?
Applicant Name (Manufacturer) :
SULZER INTRATHERAPEUTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IntraStent® Mega™ LD (Large Diameter) Stent - Biliary Indication and the IntraStent® Max™ LD (Large Diameter) Stent - Biliary Indication are intended as a palliative treatment of malignant neoplasms in the biliary tree.
Device Description
The IntraStent Mega and Max LD Stents are balloon expandable stainless steel stents with an open lattice design. The device is provided unmounted, to be manually crimped onto a noncompliant PTA balloon catheter for biliary stent expansion of choice by the physician. Upon balloon inflation the crimped stent expands to conform to the duct inner luminal surface and retains the expanded state upon balloon deflation.
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K Number
K014136Device Name
MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
Manufacturer
SULZER INTRATHERAPEUTICS, INC.
Date Cleared
2002-01-17
(31 days)
Product Code
FGE
Regulation Number
876.5010Why did this record match?
Applicant Name (Manufacturer) :
SULZER INTRATHERAPEUTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology is intended as a palliative treatment of malignant neoplasms in the biliary tree.
Device Description
The Protégé™ stent is a self-expanding nitinol (nickel-titanium alloy) stent provided in multiple lengths, (20 - 80 mm) and diameters (6 - 10 mm). The stent is electropolished. The stent is premounted on an 80 or 120 cm working length, 0.035" over-the-wire delivery catheter designed promountou on an over of Ipon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency in the biliary ducts. The disposable StarPort Delivery Technology system is comprised of an inner and outer sheath, which are locked together with a safety lock.
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K Number
K011806Device Name
PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
Manufacturer
SULZER INTRATHERAPEUTICS, INC.
Date Cleared
2001-09-07
(88 days)
Product Code
FGE
Regulation Number
876.5010Why did this record match?
Applicant Name (Manufacturer) :
SULZER INTRATHERAPEUTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology is intended as a palliative treatment of malignant neoplasms in the biliary tree.
Device Description
The Protégé™ stent is a self-expanding nitinol (nickel-titanium alloy) stent provided in multiple lengths, (20, 30, 70, 80, 80, s premounted on an 80 or 135 cm working length 6F, 0.018" (or 0.014") over-the-wire delivery catheter designed for transhepatic access. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency in the biliary ducts. The disposable StarPort Delivery Technology system is comprised of an inner and outer sheath, which are locked together with a safety lock.
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K Number
K012347Device Name
PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
Manufacturer
SULZER INTRATHERAPEUTICS, INC.
Date Cleared
2001-08-23
(30 days)
Product Code
FGE
Regulation Number
876.5010Why did this record match?
Applicant Name (Manufacturer) :
SULZER INTRATHERAPEUTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology is intended as a palliative treatment of malignant neoplasms in the biliary tree.
Device Description
The Protégé™ stent is a self-expanding nitinol (nickel-titanium alloy) stent provided in multiple lengths, (20, 30, 40, 50, 60, 70 and 80 mm) and diameters (6, 7, 8, 9 and 10 mm). The stent is electropolished. The stent is premounted on an 80 or 120 cm working length, 0.035" over-thewire delivery catheter designed for transhepatic access. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency in the biliary ducts. The disposable StarPort Delivery Technology system is comprised of an inner and outer sheath, which are locked together with a safety lock.
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K Number
K012066Device Name
PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
Manufacturer
SULZER INTRATHERAPEUTICS, INC.
Date Cleared
2001-08-01
(30 days)
Product Code
FGE
Regulation Number
876.5010Why did this record match?
Applicant Name (Manufacturer) :
SULZER INTRATHERAPEUTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology is intended as a palliative treatment of malignant neoplasms in the biliary tree.
Device Description
The Protégé™ stent is a self-expanding nitinol (nickel-titanium alloy) stent provided in multiple lengths, (20, 30, 40, 50, 60, 70 and 80 mm) and diameters (6, 7, 8 and 9 mm). The stent is electropolished. The stent is premounted on an 80 or 120 cm working length, 0.035" over-thewire delivery catheter designed for transhepatic access. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency in the biliary ducts. The disposable StarPort Delivery Technology system is comprised of an inner and outer sheath, which are locked together with a safety lock.
The modified Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology, is substantially equivalent to the currently marketed Protége™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology (K003040) in intended use, materials, technological characteristics and performance. A stent retainer feature has been added to enhance the smoothness of deployment and additional ports for enhanced contrast injection.
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