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510(k) Data Aggregation

    K Number
    K974726
    Device Name
    SUBDURAL DRAINAGE CATHETER KIT, SUBDURAL CATHETER
    Manufacturer
    ELEKTA IMPLANTS, SA
    Date Cleared
    1998-03-18

    (90 days)

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

    ELEKTA IMPLANTS, SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Subdural Drainage Catheter Kit is intended for drainage of extraventricular fluid collections, such as hygromas and chronic hematomas, into an external drainage system (such as the Suction Reservoir or the EDS or IDS Systems from Elekta) or an implanted catheter communicating with an appropriate drainage site. The patient's clinical pathology dictates whether the Subdural Drainage Catheter is connected to an internal or external drainage system.
    Device Description
    The Subdural Drainage Catheter is intended for drainage of extraventricular fluid collections, such as hygromas and chronic hematomas, into an external drainage system, (such as the Suction Reservoir or the EDS or IDS Systems from Elekta) or an implanted catheter communicating with an appropriate drainage site (i.e., peritoneum). The patient's clinical pathology dictates whether the Subdural Drainage Catheter is connected to an internal or external drainage system. The catheter is manufactured from silicone elastomer (with barium sulfate) equivalent to those of other Cordis catheters and CNS fluid shunt systems and components. The distal catheter ends in a hollow, ovoid-shaped structure ("cage") with slit-like openings. For implantation, a stylet is passed through the proximal end of the catheter, and is pushed against the interior cage bottom. This elongates the cage and allows the catheter to be passed through a 5 mm diameter burr hole. When the distal tip is appropriately placed, the stylet is removed and the catheter tip returns to its cage-like appearance.
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    K Number
    K971799
    Device Name
    PRECISION FLOW OSV II
    Manufacturer
    ELEKTA IMPLANTS, SA
    Date Cleared
    1998-02-06

    (267 days)

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

    ELEKTA IMPLANTS, SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Precision Flow 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 Orbis Sigma Valve and the Precision Flow OSV IT are both variable resistance valves that manuain a drainage rate close to the rate of CSF secretion (~ 20 ml/h) within the physiological range of intracranial pressure. The mechanism incorporates a safety pressure relief mode to prevent accidental intracranial hypertension. The principle of operation consists of a flow restricting diaphragm, a seat, and a notched pln. 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. The clearance between the seat aperture and the notched synthetic ruby nin varies depending on seat movements along the pin as pressure varies. Precision Flow OSV II and Orbis Sigma Valve are characterized by the same three stages of operation, that are defined below : Stage / - Low Differential Pressure (DP), Stage II - Flow Regulation, Stage III - Pressure Rellef Mode.
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