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

System, Hypothermia, Intravenous, Cooling

ALSIUS CORP.

The following data is part of a premarket notification filed by Alsius Corp. with the FDA for Coolgard 3000, Cooline, Start-up, Models 3000, Cl-2085b, Cl-2295a, Cg-500d.

Pre-market Notification Details

• Device ID: K014241
• 510k Number: K014241
• Device Name: COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D
• Classification: System, Hypothermia, Intravenous, Cooling
• Applicant: ALSIUS CORP. 15770 LAGUNA CANYON, SUITE 150 Irvine, CA 92618
• Contact: Ken Collins
• Correspondent: Ken Collins; ALSIUS CORP. 15770 LAGUNA CANYON, SUITE 150 Irvine, CA 92618
• Product Code: NCX
• CFR Regulation Number: 870.5900 [🔎]
• Decision: Se - With Limitations (SESU)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-12-26
• Decision Date: 2003-08-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00849111075350	K014241	000
00849111075343	K014241	000
00849111075336	K014241	000
00849111075329	K014241	000
00849111050081	K014241	000
00849111050029	K014241	000