Device Classification Name |
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
|
510(k) Number |
K880421 |
Device Name |
DESCENDING ARCH CANNULA |
Applicant |
DLP, INC. |
P.O.BOX 409 |
620 WATSONS S.W. |
GRAND RAPIDS,
MI
49501
|
|
Applicant Contact |
VAN HOF |
Correspondent |
DLP, INC. |
P.O.BOX 409 |
620 WATSONS S.W. |
GRAND RAPIDS,
MI
49501
|
|
Correspondent Contact |
VAN HOF |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 02/01/1988 |
Decision Date | 04/28/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|