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setpoint endovascular temperature probe
Radiant Medical
Summary: The SetPoint Endovascular Temperature Probe by Radiant Medical is used for controlling patient body temperature. It is typically utilized by critical care and surgical teams in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K024327 ↗
Decision Date
March 25, 2003
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The SetPoint Endovascular Temperature Probe was cleared via the FDA 510(k) pathway on March 25, 2003. It is manufactured by Radiant Medical and classified as a Class II device under product code DQY.
What It Is
The SetPoint Endovascular Temperature Probe is a medical device designed to regulate patient body temperature through endovascular means. It works by circulating a temperature-controlled fluid through a catheter placed in the venous system, allowing precise control of core body temperature. This technology is particularly useful in managing patients who require targeted temperature management.
Clinical Applications
This device is commonly used in critical care and surgical settings where precise temperature control is necessary, such as during cardiac arrest, stroke, or traumatic brain injury management. It is particularly beneficial in intensive care units and operating rooms, where maintaining normothermia or inducing hypothermia can be crucial for patient outcomes. Patients who are at risk of hyperthermia or hypothermia during complex surgical procedures may also benefit from its use.
Indications for Use
The FDA-cleared indications for this device include its use in patients who require controlled temperature management. This includes conditions where maintaining or altering body temperature can significantly impact clinical outcomes, such as in post-cardiac arrest care or neuroprotection.
Practical Considerations
The SetPoint Endovascular Temperature Probe is typically available in various sizes to accommodate different patient anatomies. It is important to ensure compatibility with existing venous access systems and to follow proper insertion techniques to minimize complications. Clinicians should be trained in its use to optimize patient safety and device efficacy.
Frequently Asked Questions
What is the SetPoint Endovascular Temperature Probe used for?
It is used for controlling and managing patient body temperature in clinical settings, particularly during critical care and surgical procedures.
What specialties typically use this device?
Critical care medicine, anesthesiology, and neurology are specialties that commonly use this device, especially in intensive care units and operating rooms.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring controlled temperature management, such as during post-cardiac arrest care or for neuroprotection.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.