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510(k) Data Aggregation
K Number
K071358Device Name
REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
Manufacturer
RADIANT MEDICAL
Date Cleared
2007-06-01
(17 days)
Product Code
NCX
Regulation Number
870.5900Why 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
K071008Device Name
REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
Manufacturer
RADIANT MEDICAL
Date Cleared
2007-05-09
(30 days)
Product Code
NCX
Regulation Number
870.5900Why 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
K063405Device Name
REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
Manufacturer
RADIANT MEDICAL
Date Cleared
2007-01-08
(60 days)
Product Code
NCX
Regulation Number
870.5900Why 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
K042388Device Name
RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBE
Manufacturer
RADIANT MEDICAL
Date Cleared
2004-10-28
(56 days)
Product Code
DQY, DOY
Regulation Number
870.1250Why 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
K024327Device Name
SETPOINT ENDOVASCULAR TEMPERATURE PROBE
Manufacturer
RADIANT MEDICAL
Date Cleared
2003-03-25
(89 days)
Product Code
DQY
Regulation Number
870.1250Why 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
K012512Device Name
SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM
Manufacturer
RADIANT MEDICAL
Date Cleared
2002-06-11
(309 days)
Product Code
NCX
Regulation Number
870.5900Why 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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