Device Classification Name |
pump, blood, cardiopulmonary bypass, roller type
|
510(k) Number |
K162843 |
Device Name |
Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1 |
Applicant |
Terumo Cardiovascular Systems Corporation |
6200 Jackson Road |
Ann Arbor,
MI
48103
|
|
Applicant Contact |
Bryan Hann |
Correspondent |
Terumo Cardiovascular Systems Corporation |
6200 Jackson Road |
Ann Arbor,
MI
48103
|
|
Correspondent Contact |
Bryan Hann |
Regulation Number | 870.4370
|
Classification Product Code |
|
Date Received | 10/11/2016 |
Decision Date | 11/17/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|