Device Classification Name |
System, Hypothermia, Intravenous, Cooling
|
510(k) Number |
K051912 |
Device Name |
COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A; ICY CATHETER KIT, MODEL IC-3585A; FORTIUS CATHETER KIT, MOD. FR-5093B |
Applicant |
ALSIUS CORP. |
15770 LAGUNA CANYON, SUITE 150 |
IRVINE,
CA
92618
|
|
Applicant Contact |
KENNETH A COLLINS |
Correspondent |
ALSIUS CORP. |
15770 LAGUNA CANYON, SUITE 150 |
IRVINE,
CA
92618
|
|
Correspondent Contact |
KENNETH A COLLINS |
Regulation Number | 870.5900
|
Classification Product Code |
|
Date Received | 07/14/2005 |
Decision Date | 10/11/2005 |
Decision |
SE - With Limitations
(SESU) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|