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510(k) Data Aggregation
K Number
K081773Device Name
OSV II
Manufacturer
INTEGRA NEUROSCIENCES IMPLANTS S.A.
Date Cleared
2008-11-06
(136 days)
Product Code
JXG
Regulation Number
882.5550Why did this record match?
Applicant Name (Manufacturer) :
INTEGRA NEUROSCIENCES IMPLANTS S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OSV II is an implantable system used in the treatment of patients with hydrocephalus, to shunt CSF from the ventricles to the peritoneal cavity or other appropriate drainage site such as the heart's right atrium.
Device Description
The OSV II is designed to shunt cerebrospinal fluid (CSF) from the ventricles of the brain to an appropriate drainage site, such as the atrium of the heart or the peritoneal cavity. Unlike conventional valves, it is a variable resistance valve which maintains a drainage rate constant within the physiological range (for the specified populations and disorders) of intracranial pressure.
The principle of operation consists of a flow restricting diaphragm, a seat, and a notched pin. The diaphragm, held between two polysulfone parts of the casing, reacts to variations in pressure. A synthetic ruby seat is inserted into the center of the diaphragm. As pressure varies, the clearance between the seat and the pin increases or decreases depending on seat movement along the pin.
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K Number
K042558Device Name
EQUI-FLOW VALVE AND SHUNT SYSTEM
Manufacturer
INTEGRA NEUROSCIENCES IMPLANTS S.A.
Date Cleared
2004-10-06
(15 days)
Product Code
JXG
Regulation Number
882.5550Why did this record match?
Applicant Name (Manufacturer) :
INTEGRA NEUROSCIENCES IMPLANTS S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Equi-Flow™ Valve and Shunt Systems are used in the treatment of patients with hydrocephalus. The device is designed to shunt cerebrospinal fluid from the ventricles of the brain to an appropriate drainage site, such as the atrium of the heart or the peritoneal cavity.
The Equi-Flow™ Valve is indicated in patients where excessive reduction of intraventricular pressure or volume may be caused by the siphoning effect of hydrostatic pressure in the Distal Catheter of the shunt system.
Device Description
The Integra NeuroSciences Equi-Flow™ Valve is a multi-function membrane valve incorporating a normally open Siphon Limiting Device, occluders, and integrant valving connectors. It is used in treatment of patients with hydrocephalus when shunting cerebrospinal fluid (CSF) from ventricles of the brain. It incorporates a central reservoir for pumping and injection, proximal and distal occluders, and a fully flexible profile.
The Siphon Limiting Device limits the siphon effect in the shunt system by closing when exposed to a negative Hydrostatic pressure (often caused by the patient sitting or standing).
The Equi-Flow Valve incorporates a central reservoir for pumping and injection, proximal and distal occluders, and a fully flexible profile. The Equi-Flow Valve design includes a flat silicone membrane, which provides resistance to CSF flow. The flat silicone membrane seats on a conical polypropylene base which is integral to the Siphon Limiting Device. This base is integral to a rigid outlet port. The design allows for accurate and precise regulation of CSF flow due to its structural integrity. The flat silicone membrane also prevents retrograde flow of CSF. The Equi-Flow valve is available in two sizes: Regular and Small. Both sizes are available in five pressure/flow characteristics ranges: Low/Low, Low, Low/Medium, Medium and High.
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K Number
K042192Device Name
LOW FLOW OSV II HYDROCEPHALUS VALVE
Manufacturer
INTEGRA NEUROSCIENCES IMPLANTS S.A.
Date Cleared
2004-09-02
(21 days)
Product Code
JXG
Regulation Number
882.5550Why did this record match?
Applicant Name (Manufacturer) :
INTEGRA NEUROSCIENCES IMPLANTS S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Low Flow OSV II Hydrocephalus Valve is an implantable system used in the treatment of patients with hydrocephalus, to shunt CSF from the ventricles to the peritoneal cavity or other appropriate drainage site such as the heart's right atrium.
Device Description
The Precision Flow OSV II and the modified Low Flow OSV II hydrocephalus valve systems are implantable devices for controlled cerebrospinal fluid drainage from the ventricles to the peritoneal cavity or other appropriate drainage site such as the heart's right atrium. Unlike conventional valves, they are variable resistance valves which maintain a drainage rate constant within the physiological range (for the specified populations and disorders) of intracranial pressure.
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K Number
K040201Device Name
MODIFICATION TO BURR HOLE VALVE AND SHUNT SYSTEM
Manufacturer
INTEGRA NEUROSCIENCES IMPLANTS S.A.
Date Cleared
2004-02-26
(28 days)
Product Code
JXG
Regulation Number
882.5550Why did this record match?
Applicant Name (Manufacturer) :
INTEGRA NEUROSCIENCES IMPLANTS S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Integra NeuroSciences Burr Hole Valve and Shunt System is used in treatment of patients with hydrocephalus. The Burr Hole Valve is a component of a system designed to shunt cerebrospinal fluid from the ventricles of the brain to an appropriate drainage site such as the atrium of the heart or to the peritoneal cavity.
Device Description
The Integra NeuroSciences Burr Hole Valve incorporates a membrane valve with integral connectors and domed reservoir to fit into a formal burr hole. It is used in treatment of patients with hydrocephalus when shunting cerebrospinal fluid (CSF) from ventricles of the brain. The Burr Hole design includes a flat silicone membrane, which provides resistance to CSF flow. The silicone membrane scats on a conical polypropylene base. This base is int4egral to a rigid outlet port. The design allows for accurate and precise regulation of CSF flow due to its structural integrity. The flat silicone membrane also prevents retrograde flow of CSF. The Burr Hole valve is available in two sizes designed to fit a 12mm or 16mm formal burr Both sizes are available in three (3) pressure/Now characteristics ranges: low, hole. medium, and high.
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K Number
K033698Device Name
CONTOUR-FLEX VALVE AND SHUNT SYSTEM
Manufacturer
INTEGRA NEUROSCIENCES IMPLANTS S.A.
Date Cleared
2003-12-17
(22 days)
Product Code
JXG
Regulation Number
882.5550Why did this record match?
Applicant Name (Manufacturer) :
INTEGRA NEUROSCIENCES IMPLANTS S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Integra NeuroSciences Contour-Flex Valve and Shunt System is used in treatment of patients with hydrocephalus. It is a component of a system designed to shunt cerebrospinal fluid from the ventricles of the brain to an appropriate drainage site such as the atrium of the heart or to the peritoneal cavity.
Device Description
The Integra NeuroSciences Contour-Flex™ Valve is a multi-function membrane valve with occluders and integral connectors. It is used in treatment of patients with hydrocephalus when shunting cerebrospinal fluid (CSF) from ventricles of the bram. It incorporates a central reservoir for pumping and injection, proximal and distal occluders, and a fully flexible profile. The Contour-Flex Valve design includes a flat siliconc membrane, which provides resistance to CSF flow. The flat silicone membrane seats on a conical polypropylene base. This base is integral to a rigid outlet port. The design allows for accurate and precise regulation of CSF flow due to its structural integrity. The flat silicone membrane also prevents retrograde flow of CSF. The Contour-Flex valve is available in two s izes: R egular a nd S mall. B oth s izes a re a vailable in 3 pressure/flow c haracteristics ranges: low, medium, and high
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K Number
K032817Device Name
EXTERNAL DRAINAGE SET
Manufacturer
INTEGRA NEUROSCIENCES IMPLANTS S.A.
Date Cleared
2003-10-06
(26 days)
Product Code
JXG
Regulation Number
882.5550Why did this record match?
Applicant Name (Manufacturer) :
INTEGRA NEUROSCIENCES IMPLANTS S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The External Drainage Sets are intended for cerebrospinal fluid (CSF) drainage, sampling and collection.
Device Description
The External Drainage Set is designed for cerebrospinal fluid (CSF) drainage, sampling and collection. The system connects to a ventricular or lumbar catheter via a Luer connection to a patient line.
The graduated cylinder of the External Drainage Set is attached to an IV pole and may be moved up and down to change positioning of the graduated cylinder by using the Velcro straps. CSF can be collected and measured in the graduated cylinder and subsequently emptied to the drainage bag by opening the stopcock placed in-line between the graduated cylinder and the drainage bag.
A hydrophobic vent filter is included in the graduated cylinder cap of the External Drainage Set. This vent filter allows air to enter the graduated cylinder to facilitate drainage from the graduated cylinder to the drainage bag while protecting the system from contamination.
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