# K030421: Alsius Coolgard 3000 & Alsius Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: Alsius Corp.
- Decided: Oct 23, 2003 after 255 days
- Product code: NCX (System, Hypothermia, Intravenous, Cooling)
- Device class: 2
- Regulation: 21 CFR 870.5900
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K811742 (1981). 14 ancestors in all.
15 later devices descend from it; 5 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012512: Setpoint Endovascular Temperature Management System, Radiant Medical (2002)
- K022366: Celsius Control System, Innercool Therapies (2003)

## Most influential descendants
- K052443: Icy Catheter, Model IC-3893A (2005), 8 descendants of its own
- K070161: Quattro Catheter Model IC4593 (2007), 7 descendants of its own
- K101987: Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter, Model IC-4593 (2010), 6 descendants of its own
- K081936: Solex Catheter, Model SL2593 (2008), 5 descendants of its own
- K150046: Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter (2015), 4 descendants of its own

## Recalls of this device
- Nov 9, 2005 · Not classified · Z-0369-06: Alsius has found that fluid spills or ingress may result in an alarm condition. The potential health risk involved in this state can be the discontinuance of therapy.
- Jul 25, 2005 · Not classified · Z-1397-05: Firm wants users to be aware not to leave the units in standby mode for more than an hour in rooms in excess of 75 F due to risk of an alarm mode being generated due to overheating.
- Nov 10, 2004 · Not classified · Z-0258-05: Product alarms that there may be a power supply interruption.
- Jun 21, 2004 · Not classified · Z-1159-04: Higher than expected rate of pump alarms occur under specific conditions.

## Indications for use
The COOLGARD™ 3000/Alsius Catheter Thermal Regulation System, using either the Icy™ or Fortius™ 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/K030421
Methodology: https://510kreport.com/methodology