| Device Classification Name |
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
|
| 510(k) Number |
K002273 |
| Device Name |
STOCKERT A272 SERIES PEDIATRIC AORTIC CANNULAE |
| Applicant |
| Stoeckert Instrumente |
| 14401 W. 65th Way |
|
Arvada,
CO
80004
|
|
| Applicant Contact |
BARBARA WATSON |
| Correspondent |
| Stoeckert Instrumente |
| 14401 W. 65th Way |
|
Arvada,
CO
80004
|
|
| Correspondent Contact |
BARBARA WATSON |
| Regulation Number | 870.4210 |
| Classification Product Code |
|
| Date Received | 07/26/2000 |
| Decision Date | 01/29/2001 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Cardiovascular
|
| 510k Review Panel |
Cardiovascular
|
| Type |
Abbreviated
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|