Device Classification Name |
blood pump for ecmo, long-term (> 6 hours) use
|
510(k) Number |
K222038 |
Device Name |
CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support System |
Applicant |
Abbott (formerly Thoratec Corporation) |
6035 Stoneridge Drive |
Pleasanton,
CA
94588
|
|
Applicant Contact |
Meera Mehta |
Correspondent |
Abbott (formerly Thoratec Corporation) |
6035 Stoneridge Drive |
Pleasanton,
CA
94588
|
|
Correspondent Contact |
Meera Mehta |
Regulation Number | 870.4100
|
Classification Product Code |
|
Date Received | 07/11/2022 |
Decision Date | 12/08/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|