# K063829: Thermogard Thermal Regulation System

- Pathway: 510(k) (Special)
- Applicant: Alsius Corp.
- Decided: Jan 22, 2007 after 27 days
- Product code: NCX (System, Hypothermia, Intravenous, Cooling)
- Device class: 2
- Regulation: 21 CFR 870.5900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Alsius CoolGard 3000 thermal regulating system: named in the summary without a submission number

## Indications for use
The Alsius Thermogard and Cool Line TM Catheter Thermal Regulation System is indicated 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. Warning - Fever Reduction The safety of this device has not been demonstrated for fever reduction in patients presenting with subarrachnoid hemorrhage or primary traumatic brain injury. The safety and effectiveness of this device was examined in a randomized controlled trial of 296 patients. The mortality results reported in this trial, for the four patient cohorts enrolled, are presented in the table below (CI - cerebral infarction, ICH - intracerebral hemorrhage, PTBI - primary traumatic brain injury, SAH - subarrachnoid hemorrhage). For more details on the clinical trial results please refer to Physician's Manual - "Normothermia for the Neuro-critically III stroke patient" #101416-001. The Alsius Thermogard/Alsius Catheter Thermal Regulation System, using either the IcyTM or FortiusTM model catheter, is indicated for use: * in cardiac surgery patients to achieve and or maintain normothermia during surgery and recovery/intensive care, and * to induce, maintain and reverse mild hypothermia in neurosurgery patients in surgery and recovery/intensive care.

Source page: https://510kreport.com/device/K063829
Methodology: https://510kreport.com/methodology