Device Classification Name |
heat-exchanger, cardiopulmonary bypass
|
510(k) Number |
K200438 |
Device Name |
MPS 3 Myocardial Protection System |
Applicant |
Quest Medical, Inc. |
One Allentown Parkway |
Allen,
TX
75002
|
|
Applicant Contact |
Tosan Onosode |
Correspondent |
Quest Medical, Inc. |
One Allentown Parkway |
Allen,
TX
75002
|
|
Correspondent Contact |
Tosan Onosode |
Regulation Number | 870.4240
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/24/2020 |
Decision Date | 06/19/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|