Device Classification Name |
heat-exchanger, cardiopulmonary bypass
|
510(k) Number |
K953838 |
Device Name |
MYOCARDIAL PROTECTION SYSTEM |
Applicant |
QUEST MEDICAL, INC. |
ONE ALLENTOWN PKWY. |
ALLEN,
TX
75002
|
|
Applicant Contact |
DREW JOHNSON |
Correspondent |
QUEST MEDICAL, INC. |
ONE ALLENTOWN PKWY. |
ALLEN,
TX
75002
|
|
Correspondent Contact |
DREW JOHNSON |
Regulation Number | 870.4240
|
Classification Product Code |
|
Date Received | 08/16/1995 |
Decision Date | 03/06/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|