Search Filters

Search Results

Found 12 results

510(k) Data Aggregation

    K Number
    K002392
    Device 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
    882.1620
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTEGRA NEUROCARE LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K992006
    Device Name
    NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33
    Manufacturer
    INTEGRA NEUROCARE LLC.
    Date Cleared
    1999-08-17

    (63 days)

    Product Code
    OCV, GCJ
    Regulation Number
    876.1500
    Why 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.
    Ask a Question
    K Number
    K981246
    Device 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
    882.5550
    Why 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
    Ask a Question
    K Number
    K973525
    Device Name
    MAURICE WORLDWIDE SHUNT SYSTEM
    Manufacturer
    INTEGRA NEUROCARE LLC.
    Date Cleared
    1997-12-16

    (90 days)

    Product Code
    JXG
    Regulation Number
    882.5550
    Why 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
    Ask a Question
    K Number
    K972994
    Device Name
    EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS
    Manufacturer
    INTEGRA NEUROCARE LLC.
    Date Cleared
    1997-11-03

    (83 days)

    Product Code
    JXG, 84J
    Regulation Number
    882.5550
    Why 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
    Ask a Question
    K Number
    K972261
    Device Name
    RIVETTI-LEVINSON INSTRALUMINAL SHUNT
    Manufacturer
    INTEGRA NEUROCARE LLC.
    Date Cleared
    1997-09-15

    (90 days)

    Product Code
    DWF, 74D
    Regulation Number
    870.4210
    Why 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
    Ask a Question
    K Number
    K971617
    Device Name
    ENDOSCOPIC VENTRICULAR CATHETER
    Manufacturer
    INTEGRA NEUROCARE LLC.
    Date Cleared
    1997-07-31

    (90 days)

    Product Code
    JXG
    Regulation Number
    882.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTEGRA NEUROCARE LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K970983
    Device Name
    PERITONEAL/CARDIAC CATHETER
    Manufacturer
    INTEGRA NEUROCARE LLC.
    Date Cleared
    1997-06-13

    (87 days)

    Product Code
    JXG, 84J
    Regulation Number
    882.5550
    Why 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
    Ask a Question
    K Number
    K970658
    Device Name
    LUMBAR DRAINAGE ACCESSORY KIT
    Manufacturer
    INTEGRA NEUROCARE LLC.
    Date Cleared
    1997-05-19

    (87 days)

    Product Code
    JXG, 84J
    Regulation Number
    882.5550
    Why 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
    Ask a Question
    K Number
    K964371
    Device Name
    SHUNT TAP WITH ICP MONITORING ACCESS PORT
    Manufacturer
    INTEGRA NEUROCARE LLC.
    Date Cleared
    1997-01-31

    (91 days)

    Product Code
    JXG
    Regulation Number
    882.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTEGRA NEUROCARE LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

    Page 1 of 2