Device Classification Name |
System, Hypothermia, Intravenous, Cooling
|
510(k) Number |
K052443 |
Device Name |
ICY CATHETER, MODEL IC-3893A |
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 | 09/06/2005 |
Decision Date | 10/17/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|