Device Classification Name |
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
|
510(k) Number |
K925442 |
Device Name |
SARNS RETROGRADE CANNULA |
Applicant |
3M HEALTH CARE, SARNS |
6200 JACKSON RD. |
PO BOX 1247 |
ANN ARBOR,
MI
48106
|
|
Applicant Contact |
NELSON L HULDIN |
Correspondent |
3M HEALTH CARE, SARNS |
6200 JACKSON RD. |
PO BOX 1247 |
ANN ARBOR,
MI
48106
|
|
Correspondent Contact |
NELSON L HULDIN |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 10/28/1992 |
Decision Date | 05/21/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|