Device Classification Name |
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
|
510(k) Number |
K915268 |
Device Name |
CATHETER TWO STAGE VENOUS RETURN |
Applicant |
DLP, INC. |
P.O.BOX 409 |
620 WATSONS S.W. |
GRAND RAPIDS,
MI
49501
|
|
Applicant Contact |
ROGER W.BRINK |
Correspondent |
DLP, INC. |
P.O.BOX 409 |
620 WATSONS S.W. |
GRAND RAPIDS,
MI
49501
|
|
Correspondent Contact |
ROGER W.BRINK |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 11/25/1991 |
Decision Date | 07/27/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|