Alsius Coolgard 3000 & Alsius Catheter System

• • Terminated Z-0369-06 FDA Unclassified (pre-2012) ·initiated 9 Nov 2005

  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.

• • Terminated Z-1397-05 FDA Unclassified (pre-2012) ·initiated 25 Jul 2005

  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.

• • Terminated Z-0258-05 FDA Unclassified (pre-2012) ·initiated 10 Nov 2004

  Product alarms that there may be a power supply interruption.

• • Terminated Z-1159-04 FDA Unclassified (pre-2012) ·initiated 21 Jun 2004

  Higher than expected rate of pump alarms occur under specific conditions.

510(k) Number

K030421 ↗

FDA Product Code

NCX

Device Class

Class II

Regulation

21 CFR Part 870.5900

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Thermogard Thermal Regulation System

  Class II

  FDA 510(k) K063829 Active Cleared 22 Jan 2007

• Solex Catheter, Model SL2593

  Class II

  FDA 510(k) K081936 Active Cleared 13 Aug 2008

• Thermogard Xp Thermal Regulation System

  Class II

  FDA 510(k) K072234 Active Cleared 23 Aug 2007

• Coolgard 3000

  Class II

  FDA 510(k) K060308 Active Cleared 26 Apr 2006

• Cool Line Catheter Kit, Models Cl-2085B, Cl-2295A; Icy Catheter Kit, Model Ic-3585A; Fortius Catheter Kit, Mod. Fr-5093B

  Class II

  FDA 510(k) K051912 Active Cleared 11 Oct 2005

• Coolgard 3000, Cooline, Start-Up, Models 3000, Cl-2085B, Cl-2295A, Cg-500D

  Class II

  FDA 510(k) K014241 Active Cleared 1 Aug 2003

See all devices from Alsius Corp. →

• What is the primary clinical use of the Alsius Coolgard 3000?

  This system is indicated as an adjunct to antipyretic therapy for patients who are intubated and sedated. It is specifically designed for individuals with cerebral infarction or intracerebral hemorrhage who require central venous access for thermal regulation.

• How does the Alsius system facilitate temperature control?

  The system functions as an integrated electro-mechanical heater and cooler unit. It utilizes an intravascular catheter to monitor and control patient temperature, facilitating fever reduction through the cooling bath interface.

• How is the device supplied for clinical use?

  The system is supplied with a disposable start-up kit. This kit is required to establish the necessary interface between the cooling bath unit and the patient catheter to ensure proper operation.

• What is the regulatory status of the Alsius Coolgard 3000?

  The Alsius Coolgard 3000 and Alsius Catheter System has received FDA 510(k) clearance under regulation number 870.5900, confirming it is substantially equivalent to other devices in its class.