| Device Classification Name |
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
|
| 510(k) Number |
K874834 |
| Device Name |
ARGYLE CARDIOPLEGIA CANNULA |
| Applicant |
| Sherwood Medical Co. |
| 1915 Olive St. |
|
St. Louis,
MO
63103 -1625
|
|
| Applicant Contact |
FRANK S MORRISON |
| Correspondent |
| Sherwood Medical Co. |
| 1915 Olive St. |
|
St. Louis,
MO
63103 -1625
|
|
| Correspondent Contact |
FRANK S MORRISON |
| Regulation Number | 870.4210 |
| Classification Product Code |
|
| Date Received | 11/24/1987 |
| Decision Date | 01/19/1988 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Cardiovascular
|
| 510k Review Panel |
Cardiovascular
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|