Device Classification Name |
catheter, intravascular, diagnostic
|
510(k) Number |
K052865 |
Device Name |
HOSPIRA CATH LAB CONVENIENCE KITS |
Applicant |
ICU MEDICAL, INC. |
275 North Field Drive |
Lake Forest,
IL
60045
|
|
Applicant Contact |
TOM KOZMA |
Correspondent |
ICU MEDICAL, INC. |
275 North Field Drive |
Lake Forest,
IL
60045
|
|
Correspondent Contact |
TOM KOZMA |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 10/11/2005 |
Decision Date | 12/22/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|