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The IQoolTM System

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K232844

by BrainCool AB

Identifiers

510(k) Number
K232844 FDA 510(k)
FDA Product Code
DWJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.5900 FDA 510(k)
Regulation Number
870.5900 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The IQool System is a thermal regulating device designed to manage body temperature during medical procedures. It employs cooling technology to reduce core body temperature, which may be applied in cardiovascular interventions to protect the myocardium and mitigate ischemic injury.

The IQool System is intended for use in clinical settings, such as cardiac catheterization labs, and is supplied as a reusable device. It is not MRI-safe and requires proper storage and maintenance as outlined in the manufacturer’s instructions. Authorized under FDA 510(k) clearance and MDD compliance, it adheres to regulatory standards for thermal regulation devices in cardiovascular applications.

Frequently asked questions

What clinical settings is the IQoolTM System primarily designed for, and how does it function in those environments?

The IQoolTM System is specifically designed for use in clinical settings like cardiac catheterization labs, where precise temperature management is critical. It employs cooling technology to reduce core body temperature during cardiovascular interventions, helping to protect the myocardium (heart muscle) and minimize ischemic injury. This makes it particularly useful during procedures where myocardial protection is a concern, such as complex coronary interventions or high-risk PCI (percutaneous coronary intervention).

Is the IQoolTM System reusable, and if so, what maintenance or storage requirements should be followed to ensure proper function?

Yes, the IQoolTM System is supplied as a reusable device, which means it must be carefully maintained and stored according to the manufacturer’s instructions to ensure reliability and safety. Since it is not MRI-safe, it cannot be used in magnetic resonance imaging environments. Proper cleaning, calibration, and storage protocols are essential to prevent contamination, damage, or performance degradation, particularly in high-use settings like catheterization labs.

What regulatory pathways has the IQoolTM System undergone, and how does this affect its use in clinical practice?

The IQoolTM System has been authorized through an FDA 510(k) clearance and complies with the Medical Devices Directive (MDD), indicating it meets regulatory standards for thermal regulating devices in cardiovascular applications. This clearance confirms that the device has been deemed substantially equivalent to a predicate device, ensuring its safety and effectiveness for managing body temperature during procedures like myocardial protection. Clinicians can rely on this regulatory backing when integrating it into their workflow.

Are there any size or model variations available for the IQoolTM System, or is it a single-unit device?

The provided data does not specify distinct size or model variations for the IQoolTM System, implying it is likely offered as a standardized reusable device tailored for general use in cardiovascular interventions. If specific configurations are required for different patient sizes or procedural needs, those details would typically be addressed in the manufacturer’s technical documentation or through consultation with BrainCool AB.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
BrainCool AB

Sources (2)

  • FDA 510(k) K232844 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026