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510(k) Data Aggregation

    K Number
    K071358
    Device Name
    REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
    Manufacturer
    RADIANT MEDICAL
    Date Cleared
    2007-06-01

    (17 days)

    Product Code
    NCX
    Regulation Number
    870.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    RADIANT MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Radiant Medical Reprieve® Endovascular Temperature Therapy System is a thermal regulating device intended to induce, maintain, and reverse mild hypothermia in neurosurgical patients in surgery and in recovery/intensive care.
    Device Description
    The Reprieve System consists of a single-use, heparin-coated, central venous catheter; a single-use, heat exchange cassette; an integrated temperature probe; and an external controller. The Controller unit has a user interface to select operating parameters and is connected to the Catheter via the Cassette and extension lines. The catheter is designed for placement in the inferior vena cava via the femoral vein using a 12 Fr hemostatic introducer sheath.
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    K Number
    K071008
    Device Name
    REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
    Manufacturer
    RADIANT MEDICAL
    Date Cleared
    2007-05-09

    (30 days)

    Product Code
    NCX
    Regulation Number
    870.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    RADIANT MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Reprieve Endovascular Temperature Therapy System is a thermal regulating system intended to achieve and/or maintain normothermia in cardiac surgery patients in surgery and in recovery/intensive care, and for use in fever reduction, as an adjunct to other antipyretic therapy, in patients with cerebral infarction and intracerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated.
    Device Description
    Not Found
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    K Number
    K063405
    Device Name
    REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
    Manufacturer
    RADIANT MEDICAL
    Date Cleared
    2007-01-08

    (60 days)

    Product Code
    NCX
    Regulation Number
    870.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    RADIANT MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Radiant Medical Reprieve® Endovascular Temperature Therapy System is indicated for use in cardiac surgery patients to achieve and/or maintain normothermia during surgery and recovery/intensive care.
    Device Description
    The Reprieve System consists of a single-use, heparin-coated, central venous catheter; a single-use, heat exchange cassette; an integrated temperature probe; and an external controller. The Controller unit has a user interface to select operating parameters and is connected to the Catheter via the Cassette and extension lines. The catheter is designed for placement in the inferior vena cava via the femoral vein using a 12 Fr hemostatic introducer sheath.
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    K Number
    K042388
    Device Name
    RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBE
    Manufacturer
    RADIANT MEDICAL
    Date Cleared
    2004-10-28

    (56 days)

    Product Code
    DQY, DOY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    RADIANT MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Radiant Medical Endocatheter Temperature Probe is indicated for use with the SetPoint/Reprieve Endovascular Temperature Management System to measure core body temperature.
    Device Description
    The Endocatheter Temperature Probe consists of a sheath containing two thermistors on separate and independent circuits. This Probe is intended for placement into the inferior vena cava through the guidewire lumen of the catheter. The outer sheath is Pebax and has a soft, straight Pebax tip. The Endocatheter Probe is heparin-coated for hemocompatibility. The intended use is to measure a patient's core body temperature via venous blood temperature. The Endocatheter Probe is for single use only. It is provided sterile and packaged in a Tyvek/polyethylene pouch. Sterilization is by gamma irradiation.
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    K Number
    K024327
    Device Name
    SETPOINT ENDOVASCULAR TEMPERATURE PROBE
    Manufacturer
    RADIANT MEDICAL
    Date Cleared
    2003-03-25

    (89 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    RADIANT MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SetPoint® Endovascular Temperature Probe is indicated for use with the SetPoint Endovascular Temperature Management System to measure core body temperature.
    Device Description
    The SetPoint Endovascular Temperature Probe consists of a sheath containing two 400-series equivalent thermistors on separate and independent circuits. This Probe is intended for endovascular placement similar to other venous catheters with temperature measurement capability, including the Arrow International Inc. Multi-Lumen Central Venous Catheter (K904404). The outer sheath is Pebax and has a soft, straight Pebax tip. The Endovascular Probe is heparin-coated for hemocompatibility. It is compatible with a 4 Fr. introducer with Touhy-Borst hemostasis valve. The intended use is to measure a patient's core body temperature via venous blood temperature. The Endovascular Probe is for single use only. It is provided sterile and packaged in a polyethylene/Tyvek pouch. Sterilization is by gamma irradiation.
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    K Number
    K012512
    Device Name
    SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM
    Manufacturer
    RADIANT MEDICAL
    Date Cleared
    2002-06-11

    (309 days)

    Product Code
    NCX
    Regulation Number
    870.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    RADIANT MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the SetPoint® System is to raise, lower, and/or maintain blood temperature. The SetPoint® System is indicated for use in cardiac surgery patients to achieve and/or maintain normothermia during surgery and recovery/intensive carc.
    Device Description
    The SetPoint System is used to raise, lower, and/or maintain blood temperature. It consists of a single-use, heparin-coated, central venous catheter; a single-use, heat exchange cassette; an external controller; and associated accessories. The Controller unit has a user interface to select operating parameters and is connected to the Catheter via insulated lines. The catheter is designed for placement in the inforior vena cava via the femoral vein using a 10 Fr hemostatic introducer sheath. The Cassette is an integral part to the Catheter and an interface to the Controller.
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