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510(k) Data Aggregation

    K Number
    K141869
    Device Name
    QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT
    Manufacturer
    HEMEDEX INCORPORATED
    Date Cleared
    2014-10-10

    (91 days)

    Product Code
    GWM, HBG
    Regulation Number
    882.1620
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEMEDEX INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hemedex Cranial Bolt is designed to achieve cranial access and to introduce and secure one to four sensors in place for intracranial monitoring.
    Device Description
    The QFlow 500™ Titanium Bolt Quad Lumen Kit is used to achieve cranial access and to introduce and secure up to four sensors in place for intracranial monitoring. The kit contains a cranial bolt, drill bit, scalpel, sensor introducer with stylet, Touhy Borst fittings and connectors. The cranial bolt contains four lumens with its primary materials being titanium, polyphenylsulfone, polyvinyl chloride and polycarbonate. The primary materials of the sensor introducer are polyether block amide and polycarbonate. The primary materials of the other components in the kit are stainless steel, titanium nitride, acrylonitrile butadiene styrene, polyphenylsulfone, polyvinyl chloride and polycarbonate.
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    K Number
    K032127
    Device Name
    HEMEDEX FIXATION DEVICE
    Manufacturer
    HEMEDEX INCORPORATED
    Date Cleared
    2003-12-30

    (173 days)

    Product Code
    KNY, DPT, DPW, FGE
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEMEDEX INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hemedex Fixation Device is intended to be used on the patient's skin to secure the percutaneous placement of the QFlow Perfusion Probe.
    Device Description
    The Hemedex Fixation Device is a compact soft silicone disk with a securing clamp and adhesive dressing for securing a probe or catheter to the patients skin. The clear pressure sensitive adhesive dressing allows for easy visual inspection of catheter entry site.
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    K Number
    K032337
    Device Name
    HEMEDEX CRANIAL BOLT MODELS, 3601, 3602
    Manufacturer
    HEMEDEX INCORPORATED
    Date Cleared
    2003-10-21

    (84 days)

    Product Code
    GWM
    Regulation Number
    882.1620
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEMEDEX INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hemedex Single and Double Lumen Bolts are designed to achieve cranial access and to introduce and secure a sensor in place for intracranial monitoring.
    Device Description
    The Hemedex Cranial Bolts are stainless steel threaded cranial access devices with standard tuohy borst compression fittings.
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    K Number
    K013376
    Device Name
    QFLOW 500 PERFUSION MONITORING SYSTEM
    Manufacturer
    HEMEDEX INCORPORATED
    Date Cleared
    2002-05-08

    (209 days)

    Product Code
    DPW
    Regulation Number
    870.2100
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEMEDEX INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The QFlow™ 500 is intended for extravascular monitoring of microcirculation blood flow in buried tissues. Example of this application included (but are not limited to) 1) the monitoring of buried muscle or esophagus following free muscle transfer or esophageal reconstruction, 2) monitoring soft tissue microcirculation following reconstructive surgery, such as oral and facial reconstruction, 3) monitoring cerebral blood flow during and following neurosurgery for head trauma.
    Device Description
    The QFlow™ 500 has application where real-time determination of any tissue perfusion is desired, whether it is for measurement or monitoring utilization. The system may be used in the Intensive Care Unit, Operating Room, Radiology Suite or in a standard patient care room. However, the system is not designed for use during patient transport. The QFlow™ 500 consists of a thermal diffusion probe and a monitor. The QFlow™ 500 Perfusion System Probe thermally interacts with tissue. It contains two thermistors embedded at the distal tip of the probe. It is available in a range of lengths from 60 cm to 120 cm and less than 1 mm in diameter. The probe contains an EEPROM for the storage of probespecific calibration data, data on the cumulative time the probe has been in use, and a verification key to insure the origin of the probe. The probe connector physically connects the probe to the umbilical cord which connects to the monitor. The QFlow™ 500 Monitor controls the thermistors in the Probe. Perfusion data are displayed on the monitor. The current perfusion value, temperature and thermal conductivity are be displayed in numeric form. The data are also displayed in the form of a graph as a function of time. The monitor is capable of storing data for up to 10 days. All of this stored data may be reviewed by the user at any time during this period. Printing of data is also an option from the monitor. There is also the capability of uploading data from the monitor to an external computer for further analysis.
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