Device Classification Name |
pump, blood, cardiopulmonary bypass, non-roller type
|
510(k) Number |
K992592 |
Device Name |
A-MINIATURE CENTRIFUGAL BLOOD PUMP SYSTEM, MODEL CPB 2000 |
Applicant |
A-MED SYSTEMS, INC. |
2491 BOATMAN AVE. |
WEST SACRAMENTO,
CA
95691
|
|
Applicant Contact |
ROBERTA THOMPSON |
Correspondent |
A-MED SYSTEMS, INC. |
2491 BOATMAN AVE. |
WEST SACRAMENTO,
CA
95691
|
|
Correspondent Contact |
ROBERTA THOMPSON |
Regulation Number | 870.4360
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/02/1999 |
Decision Date | 05/04/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|