Atlas FDA

COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D

FDA 510(k) clearance K014241 · decided 2003-08-01

Clearance details

K-number
K014241
Device name
COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D
Applicant
Alsius Corp.
Decision
Unknown
Date received
2001-12-26
Decision date
2003-08-01
Days to decision
583 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

RecordFirmDate
Alsius Cool Line Catheter, Model CL-2295A recall (Z-0502-2007)Alsius Corporation2007-02-15
Alsius Cool Line Catheter, Model CL-2295AE recall (Z-0503-2007)Alsius Corporation2007-02-15
Alsius CoolGard Temperature Regulation System recall (Z-0369-06)Alsius Corporation2006-01-10
Alsius CoolGard 3000 Temperature Regulation System recall (Z-1397-05)Alsius Corporation2005-08-24
Alsius CoolGard 3000 patient temperature regulation system recall (Z-0258-05)Alsius Corporation2004-11-25
Alsius CoolGuard 3000 Temperature Regulation System, Model CoolGuard 3000 recall (Z-1159-04)Alsius Corporation2004-07-23