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Found 12 results
510(k) Data Aggregation
K Number
K002392Device Name
VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V
Manufacturer
INTEGRA NEUROCARE LLC.
Date Cleared
2000-11-02
(87 days)
Product Code
GWM
Regulation Number
882.1620Why did this record match?
Applicant Name (Manufacturer) :
INTEGRA NEUROCARE LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K992006Device Name
NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33
Manufacturer
INTEGRA NEUROCARE LLC.
Date Cleared
1999-08-17
(63 days)
Product Code
OCV, GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
INTEGRA NEUROCARE LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Neuroview® Instrument Holder (Model: 300-33) is intended for use in holding Neuro Navigational Neuroview Endoscopes in a desired position over the patient during diagnostic and therapeutic procedures.
Device Description
The Neuroview Instrument Holder, Model 300-33, is a reusable, stainless steel accessory used to hold currently marketed Neuro Navigational Endoscopes. The holder consists of a rail clamp, adjustable stainless steel rods, toggle clamps, and an instrument clamp.
This Instrument Holder, as well as the predicate devices, includes a one-piece design that is completely stable when used to position an instrument. The arms contain adjustable stainless steel clamps and holders that will adapt to any operating room table and hold any Neuro Navigational Endoscope. The holder can be positioned over the patient and locked into place to facilitate accurate Endoscope manipulation and instrument passage. The Instrument Holder, as well as the predicates accessory devices, is sold non-sterile and autoclavable for rapid operating room preparation.
This Instrument Holder is intended to hold the Neuroview Endoscope in place. It has no direct contact with the patient. The only important performance aspect of the Instrument Holder is that it maintains its position once it has been positioned and tightened in place.
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K Number
K981246Device Name
BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730)
Manufacturer
INTEGRA NEUROCARE LLC.
Date Cleared
1999-05-26
(415 days)
Product Code
JXG
Regulation Number
882.5550Why did this record match?
Applicant Name (Manufacturer) :
INTEGRA NEUROCARE LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Beverly Referential Valve, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles of the brain into either the peritoneum or the right atrium of the heart.
The Beverly Referential Valve is intended to minimize the effect of hydrostatically induced flow when the patient is sitting, standing or semi-recumbent when compared to devices not containing an anti-siphon device.
This device should only be used by a physician or qualified personnel under the direction of a physician.
Care must be taken to ensure compliance with the manufacturer's instructions for use.
Prescription Use Only (Per 21 CFR 801.109)
Device Description
Beverly Referential Valve
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K Number
K973525Device Name
MAURICE WORLDWIDE SHUNT SYSTEM
Manufacturer
INTEGRA NEUROCARE LLC.
Date Cleared
1997-12-16
(90 days)
Product Code
JXG
Regulation Number
882.5550Why did this record match?
Applicant Name (Manufacturer) :
INTEGRA NEUROCARE LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Maurice Worldwide Shunt System is utilized in the treatment of hydrocephalic patients. It is a component in systems designed to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneal cavity.
Device Description
Not Found
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K Number
K972994Device Name
EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS
Manufacturer
INTEGRA NEUROCARE LLC.
Date Cleared
1997-11-03
(83 days)
Product Code
JXG, 84J
Regulation Number
882.5550Why did this record match?
Applicant Name (Manufacturer) :
INTEGRA NEUROCARE LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The major indication for use of the External CSF Drainage Management Systems is the management of hydrocephalic shunt infections. If an internal shunt is not indicated, treatment of other cerebral conditions such as pre-operative drainage, intraventricular hemorrhage and post-operative pressure monitoring may also require external drainage to control increased intracranial pressure.
Device Description
External CSF Drainage Management Systems
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K Number
K972261Device Name
RIVETTI-LEVINSON INSTRALUMINAL SHUNT
Manufacturer
INTEGRA NEUROCARE LLC.
Date Cleared
1997-09-15
(90 days)
Product Code
DWF, 74D
Regulation Number
870.4210Why did this record match?
Applicant Name (Manufacturer) :
INTEGRA NEUROCARE LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Rivetti-Levinson Intraluminal Shunt is indicated for use in preventing ischemia during the construction of coronary artery bypass grafts (either saphenous vein or of mammary artery) in the non-arrested heart.
Intraluminal shunting is indicated for temporary perfusion of the distal coronary lumen as an adjunct to the surgical technique and as a mechanism to prevent myocardial ischemia while the target coronary artery is opened and surgically grafted to a donor vessel.
Device Description
Not Found
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K Number
K971617Device Name
ENDOSCOPIC VENTRICULAR CATHETER
Manufacturer
INTEGRA NEUROCARE LLC.
Date Cleared
1997-07-31
(90 days)
Product Code
JXG
Regulation Number
882.5550Why did this record match?
Applicant Name (Manufacturer) :
INTEGRA NEUROCARE LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K970983Device Name
PERITONEAL/CARDIAC CATHETER
Manufacturer
INTEGRA NEUROCARE LLC.
Date Cleared
1997-06-13
(87 days)
Product Code
JXG, 84J
Regulation Number
882.5550Why did this record match?
Applicant Name (Manufacturer) :
INTEGRA NEUROCARE LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Peritoneal/Cardiac Catheter is utilized in the treatment of hydrocephalic patients. It is a component in systems designed to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into either the peritoneal cavity of the right atrium of the heart. A ventriculoperitoneal shunting system may be indicated to avoid the cardiovascular complications of an atrial shunt or for a hydrocephalic patient in whom an atrial shunt is contraindicated.
Device Description
Not Found
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K Number
K970658Device Name
LUMBAR DRAINAGE ACCESSORY KIT
Manufacturer
INTEGRA NEUROCARE LLC.
Date Cleared
1997-05-19
(87 days)
Product Code
JXG, 84J
Regulation Number
882.5550Why did this record match?
Applicant Name (Manufacturer) :
INTEGRA NEUROCARE LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The major indication of external drainage is the management of hydrocephalic shunt infections. External drainage of cerebrospinal fluid (CSF) to control increased intercranial pressure may also be indicated if an internal shunt is not indicated or during the treatment of other cerebral conditions such as pre-operative drainage, intraventricular hemorrhage and post-operative pressure monitoring. This device should only be used by a physician or qualified personnel under the direction of a physician.
Device Description
Lumbar Drainage Accessory Kit
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K Number
K964371Device Name
SHUNT TAP WITH ICP MONITORING ACCESS PORT
Manufacturer
INTEGRA NEUROCARE LLC.
Date Cleared
1997-01-31
(91 days)
Product Code
JXG
Regulation Number
882.5550Why did this record match?
Applicant Name (Manufacturer) :
INTEGRA NEUROCARE LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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