Device Classification Name |
Control, Pump Speed, Cardiopulmonary Bypass
|
510(k) Number |
K131179 |
Device Name |
CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR |
Applicant |
THORATEC CORP |
23 4th Ave |
BURLINGTON,
MA
01803
|
|
Applicant Contact |
YVERRE BOBAY |
Correspondent |
THORATEC CORP |
23 4th Ave |
BURLINGTON,
MA
01803
|
|
Correspondent Contact |
YVERRE BOBAY |
Regulation Number | 870.4380
|
Classification Product Code |
|
Date Received | 04/25/2013 |
Decision Date | 07/18/2013 |
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
|
|
|