# Alsius Corp.

- Location (FDA's records): Irvine, CA
- FDA decisions: 9 (2003–2008): 9 510(k) clearances
- Product codes: NCX (9)
- Predicates its devices cite: 11 (5 its own); citations of its devices by later devices: 16 (5 its own)
- Recalls linked to its devices: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Arrow Intl., Inc.: 2 (https://510kreport.com/company/arrow-intl)
- Radiant Medical: 1 (https://510kreport.com/company/radiant-medical)
- Innercool Therapies: 1 (https://510kreport.com/company/innercool-therapies)
- Alpha Omega, Ltd.: 1 (https://510kreport.com/company/alpha-omega)
- Mtre Advanced Technology, Ltd.: 1 (https://510kreport.com/company/mtre-advanced-technology)

## Firms that cite its devices most
- Zoll Circulation, Inc.: 8 (https://510kreport.com/company/zoll-circulation)
- Innercool Therapies: 2 (https://510kreport.com/company/innercool-therapies)
- Radiant Medical: 1 (https://510kreport.com/company/radiant-medical)

## Its most-cited devices
- K030421: Alsius Coolgard 3000 & Alsius Catheter System (2003), cited by 5
- K014241: Coolgard 3000, Cooline, Start-UP, Models 3000, CL-2085B, CL-2295A, CG-500D (2003), cited by 5
- K052443: Icy Catheter, Model IC-3893A (2005), cited by 2
- K060308: Coolgard 3000 (2006), cited by 1
- K081936: Solex Catheter, Model SL2593 (2008), cited by 1
- K070161: Quattro Catheter Model IC4593 (2007), cited by 1

## Recent decisions
- K081936: Solex Catheter, Model SL2593 (Aug 13, 2008)
- K072234: Thermogard XP Thermal Regulation System (Aug 23, 2007)
- K070161: Quattro Catheter Model IC4593 (Feb 15, 2007)
- K063829: Thermogard Thermal Regulation System (Jan 22, 2007)
- K060308: Coolgard 3000 (Apr 26, 2006)
- K052443: Icy Catheter, Model IC-3893A (Oct 17, 2005)
- K051912: Cool Line Catheter Kit, Models CL-2085B, CL-2295A; Icy Catheter Kit, Model IC-3585A; Fortius Catheter Kit, Mod. FR-5093B (Oct 11, 2005)
- K030421: Alsius Coolgard 3000 & Alsius Catheter System (Oct 23, 2003)

Source page: https://510kreport.com/company/alsius