Device Classification Name |
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
|
510(k) Number |
K080034 |
Device Name |
THREE STAGE VENOUS RETURN CANNULA, MODEL 816460 |
Applicant |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
6200 JACKSON RD. |
ANN ARBOR,
MI
48103
|
|
Applicant Contact |
ANDREA WALLEN |
Correspondent |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
6200 JACKSON RD. |
ANN ARBOR,
MI
48103
|
|
Correspondent Contact |
ANDREA WALLEN |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 01/07/2008 |
Decision Date | 06/17/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|