Device Classification Name |
container, empty, for collection & processing of blood & blood components
|
510(k) Number |
BK900016 |
Tradename |
Closed System Apheresis Kit CS-3000 Blood Cell Separator (single venous access for platelet collection)
|
Device Name |
Container, Empty, For the Collection '& Processing of Blood/Blood Components |
Original Applicant |
Fenwal Inc |
three corporate drive |
lake zurich,
IL
60047
|
|
Regulation Number | 864.9100
|
Classification Product Code |
|
Date Received | 04/05/1990 |
Decision Date | 06/07/1991 |
Decision |
substantially equivalent (SE) |
Classification Advisory Committee |
Hematology
|
Review Advisory Committee |
Hematology
|
Type |
510(k) Traditional
|
Total Product Life Cycle (TPLC) |
TPLC Device Report
|
Reviewed by Third Party |
No
|
Expedited Review |
No
|
Combination Product |
No
|
In Vitro Product |
No
|
|
|