Device Classification Name |
console, heart-lung machine, cardiopulmonary bypass
|
510(k) Number |
K221895 |
Device Name |
Terumo Advanced Perfusion System 1 |
Applicant |
Terumo Cardiovascular Systems Corporation |
6200 Jackson Road |
Ann Arbor,
MI
48103
|
|
Applicant Contact |
Eileen Dorsey |
Correspondent |
Terumo Cardiovascular Systems Corporation |
6200 Jackson Road |
Ann Arbor,
MI
48103
|
|
Correspondent Contact |
Eileen Dorsey |
Regulation Number | 870.4220
|
Classification Product Code |
|
Date Received | 06/30/2022 |
Decision Date | 04/18/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|