Device Classification Name |
heat-exchanger, cardiopulmonary bypass
|
510(k) Number |
K041979 |
Device Name |
MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260 |
Applicant |
QUEST MEDICAL, INC. |
ONE ALLENTOWN PKWY. |
ALLEN,
TX
75002
|
|
Applicant Contact |
JANE ANN MARTIN |
Correspondent |
QUEST MEDICAL, INC. |
ONE ALLENTOWN PKWY. |
ALLEN,
TX
75002
|
|
Correspondent Contact |
JANE ANN MARTIN |
Regulation Number | 870.4240
|
Classification Product Code |
|
Date Received | 07/23/2004 |
Decision Date | 09/02/2004 |
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
|
|
|