Device Classification Name |
controller, temperature, cardiopulmonary bypass
|
510(k) Number |
K140012 |
Device Name |
SORIN FLEXTHERM |
Applicant |
SORIN GROUP DEUTSCHLAND GMBH |
14401 W 65TH WAY |
ARVADA,
CO
80004
|
|
Applicant Contact |
SCOTT LIGHT |
Correspondent |
SORIN GROUP DEUTSCHLAND GMBH |
14401 W 65TH WAY |
ARVADA,
CO
80004
|
|
Correspondent Contact |
SCOTT LIGHT |
Regulation Number | 870.4250
|
Classification Product Code |
|
Date Received | 01/02/2014 |
Decision Date | 01/31/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|