Device Classification Name |
heat-exchanger, cardiopulmonary bypass
|
510(k) Number |
K173716 |
Device Name |
MPS2 Myocardial Protection System Console |
Applicant |
Quest Medical, Inc. |
One Allentown Parkway |
Allen,
TX
75002 -4211
|
|
Applicant Contact |
Jan Hodges |
Correspondent |
Experien Group |
224 Airport Parkway |
San Jose,
CA
95110
|
|
Correspondent Contact |
Ronald S Warren |
Regulation Number | 870.4240
|
Classification Product Code |
|
Date Received | 12/05/2017 |
Decision Date | 10/01/2018 |
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
|
|
|