Device Classification Name |
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
|
510(k) Number |
K041697 |
Device Name |
TERUMO CIRCUIT CONNECTORS |
Applicant |
Terumo Cardiovascular Systems Corporation |
125 BLUE BALL RD. |
ELKTON,
MD
21921
|
|
Applicant Contact |
GARRY A COURTNEY |
Correspondent |
Terumo Cardiovascular Systems Corporation |
125 BLUE BALL RD. |
ELKTON,
MD
21921
|
|
Correspondent Contact |
GARRY A COURTNEY |
Regulation Number | 870.4290
|
Classification Product Code |
|
Date Received | 06/22/2004 |
Decision Date | 08/11/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|