ClearanceBrief
510(k) K014241 ยท NCX System, Hypothermia, Intravenous, Cooling

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

ApplicantAlsius Corp., Irvine CA, US
DecisionUnknown, Aug 1, 2003
ReceivedDec 26, 2001
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K014241

DateFirm and productCodeLinked 510(k)
Feb 15, 2007Alsius Corporation
Alsius Cool Line Catheter, Model CL-2295A
Terminated		 NCXNone listed
Feb 15, 2007Alsius Corporation
Alsius Cool Line Catheter, Model CL-2295AE
Terminated		 NCXNone listed
Jan 10, 2006Alsius Corporation
Alsius CoolGard Temperature Regulation System
Terminated		 NCXNone listed
Aug 24, 2005Alsius Corporation
Alsius CoolGard 3000 Temperature Regulation System
Terminated		 NCXNone listed
Nov 25, 2004Alsius Corporation
Alsius CoolGard 3000 patient temperature regulation system
Terminated		 NCXNone listed
Jul 23, 2004Alsius Corporation
Alsius CoolGuard 3000 Temperature Regulation System, Model CoolGuard 3000
Terminated		 NCXNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.