ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM
FDA 510(k) clearance K030421 · decided 2003-10-23
Clearance details
- K-number
- K030421
- Device name
- ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM
- Applicant
- Alsius Corp.
- Decision
- Substantially Equivalent
- Date received
- 2003-02-10
- Decision date
- 2003-10-23
- Days to decision
- 255 days
- Clearance type
- Traditional
- Product code
- NCX
- Device class
- 2
- Regulation number
- 870.5900
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Alsius CoolGard Temperature Regulation System recall (Z-0369-06) | Alsius Corporation | 2006-01-10 |
| Alsius CoolGard 3000 Temperature Regulation System recall (Z-1397-05) | Alsius Corporation | 2005-08-24 |
| Alsius CoolGard 3000 patient temperature regulation system recall (Z-0258-05) | Alsius Corporation | 2004-11-25 |
| Alsius CoolGuard 3000 Temperature Regulation System, Model CoolGuard 3000 recall (Z-1159-04) | Alsius Corporation | 2004-07-23 |