Device Classification Name |
Console, Heart-Lung Machine, Cardiopulmonary Bypass
|
510(k) Number |
K163531 |
Device Name |
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 | 870.4220
|
Classification Product Code |
|
Date Received | 12/16/2016 |
Decision Date | 06/07/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|