Device Classification Name |
catheter, intravascular, diagnostic
|
510(k) Number |
K063784 |
Device Name |
DYE MANAGEMENT SYSTEM |
Applicant |
ICU MEDICAL, INC |
4455 ATHERTON DR. |
SALT LAKE CITY,
UT
84123
|
|
Applicant Contact |
MARTIN MAIER |
Correspondent |
ICU MEDICAL, INC |
4455 ATHERTON DR. |
SALT LAKE CITY,
UT
84123
|
|
Correspondent Contact |
MARTIN MAIER |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 12/21/2006 |
Decision Date | 04/16/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|