Device Classification Name |
Apparatus, Autotransfusion
|
510(k) Number |
K012178 |
Device Name |
FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW |
Applicant |
FRESENIUS HEMOTECHNOLOGY, INC. |
6675 185TH AVE. NE, SUITE 100 |
REDMOND,
WA
98052
|
|
Applicant Contact |
TOM TROTTER |
Correspondent |
FRESENIUS HEMOTECHNOLOGY, INC. |
6675 185TH AVE. NE, SUITE 100 |
REDMOND,
WA
98052
|
|
Correspondent Contact |
TOM TROTTER |
Regulation Number | 868.5830
|
Classification Product Code |
|
Date Received | 07/12/2001 |
Decision Date | 07/23/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|