Device Classification Name |
catheter, cannula and tubing, vascular, cardiopulmonary bypass
|
510(k) Number |
K905224 |
Device Name |
CARDIOPULMONARY BYPASS VASCULAR CATHETER |
Applicant |
3M HEALTH CARE, SARNS |
6200 JACKSON RD. |
PO BOX 1247 |
ANN ARBOR,
MI
48106
|
|
Applicant Contact |
JAMES BLUN |
Correspondent |
3M HEALTH CARE, SARNS |
6200 JACKSON RD. |
PO BOX 1247 |
ANN ARBOR,
MI
48106
|
|
Correspondent Contact |
JAMES BLUN |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 11/20/1990 |
Decision Date | 02/05/1991 |
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
|
|
|