Device Classification Name |
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
|
510(k) Number |
K201068 |
Device Name |
Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortiva BioActive Surface |
Applicant |
Medtronic, Inc. |
7611 Northland Drive |
Minneapolis,
MN
55428
|
|
Applicant Contact |
Sammie C. Joseph-Fredericks |
Correspondent |
Medtronic, Inc. |
7611 Northland Drive |
Minneapolis,
MN
55428
|
|
Correspondent Contact |
Sammie C. Joseph-Fredericks |
Regulation Number | 870.4360
|
Classification Product Code |
|
Date Received | 04/22/2020 |
Decision Date | 05/21/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|