Device Classification Name |
console, heart-lung machine, cardiopulmonary bypass
|
510(k) Number |
K210130 |
Device Name |
Stockert S5 System |
Applicant |
LivaNova Deutschland GmbH |
Lindberghstr. 25 |
Munich,
DE
80939
|
|
Applicant Contact |
Florian Goetz |
Correspondent |
LivaNova Deutschland GmbH |
Lindberghstr. 25 |
Munich,
DE
80939
|
|
Correspondent Contact |
Florian Goetz |
Regulation Number | 870.4220
|
Classification Product Code |
|
Date Received | 01/19/2021 |
Decision Date | 04/05/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|