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510(k) Data Aggregation
K Number
K051379Device Name
PROTEGE RX GPS SELF-EXPANDING NITRINOL STENT
Manufacturer
EV3 CORPORATION
Date Cleared
2005-06-17
(21 days)
Product Code
FGE
Regulation Number
876.5010Why did this record match?
Applicant Name (Manufacturer) :
EV3 CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Protégé® RX GPS™ Self-Expanding Nitinol Stent is intended as a palliative treatment of malignant neoplasms in the biliary tree.
Device Description
The Protégé stent is a self-expanding nitinol stent with an open lattice design. The stent is electropolished. The device is provided premounted on a delivery catheter. Upon lo elour porthe constrained stent self-expands to conform to the duct inner luminal surface.
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K Number
K050725Device Name
PROTEGE GPS SELF-EXPANDING NITINOL STENT
Manufacturer
EV3 CORPORATION
Date Cleared
2005-04-20
(30 days)
Product Code
FGE
Regulation Number
876.5010Why did this record match?
Applicant Name (Manufacturer) :
EV3 CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Protégé® GPS™ Self-Expanding Nitinol Stent is intended as a palliative treatment of malignant neoplasms in the biliary tree.
The Protégé® GPS™ Self-Expanding Nitinol Stent is indicated for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Device Description
The Protégé stent is a self-expanding nitimol stent with an open lattice design. The stent is electropolished. The device is provided premounted on a delivery catheter. Upon deployment the constrained stent self-expands to conform to the duct inner luminal surface.
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K Number
K021096Device Name
X-SIZER CATHETER SYSTEM
Manufacturer
EV3 CORPORATION
Date Cleared
2004-09-08
(888 days)
Product Code
MCW
Regulation Number
870.4875Why did this record match?
Applicant Name (Manufacturer) :
EV3 CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The X-SIZER Catheter System is indicated for the mechanical removal of thrombus in synthetic hemodialysis grafts.
Device Description
The X-SIZER System is a single-use, disposable medical device intended for the selective removal of thrombus from blood vessels. The device consists of a 135cm coaxial, dual lumen hydrophilic coated outer catheter shaft connected to a hand-held Control Module. The inner lumen of the catheter is composed of a hollow torque cable encapsulated in a polyamide tube (flexible drive shaft). A helical cutter is contained within the cutter housing located at the distal tip of the catheter. The outer lumen of the catheter is the path in which the excised debris is removed by vacuum. In use, the cutter is rotated at approximately 2,100 pm by the motor, which is powered by a 9-volt alkaline battery. In addition to turning the helical cutter, the inner lumen provides the space through which a coronary guidewire is placed. The hand-held Control Module contains the motor, battery, circuitry, indicators, and various valves and manifolds for the vacuum removal of thrombotic debris. The X-SIZER System is available in the 1.5mm and 2.0mm diameter models.
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K Number
K031864Device Name
NITREX NITINOL GUIDEWIRE
Manufacturer
EV3 CORPORATION
Date Cleared
2003-06-24
(8 days)
Product Code
DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
EV3 CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 0.035'' and 0.025'' Guidewire is indicated for use in the peripheral vasculature. The 0.014'', 0.016'', and 0.018'' guidewires are indicated for use in the peripheral and coronary vasculature.
Device Description
The guidewire is constructed of nitinol (nickel-titanium alloy). The nitinol core extends from the distal tip of the guidewire to the proximal shaft end. The distal tip is a helically coiled coil gold plated tungsten wire. The guidewire is coated with a coating(s)to help facilitate smooth passage.
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K Number
K024021Device Name
NITREX NITINOL GUIDEWIRE
Manufacturer
EV3 CORPORATION
Date Cleared
2003-01-24
(50 days)
Product Code
DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
EV3 CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 0.035" and 0.025" Guidewire is indicated for use in the peripheral vasculature. The 0.014", 0.016", and 0.018" guidewires are indicated for use in the peripheral and coronary vasculature.
Device Description
The guidewire is constructed of nitinol (nickel-titanium alloy). The nitinol core extends from the distal tip of the guidewire to the proximal shaft end. The distal tip is a helically coiled coil gold plated tungsten wire. The guidewire is coated with a coating(s)to help facilitate smooth passage.
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