Device Classification Name |
oxygenator, cardiopulmonary bypass
|
510(k) Number |
K912655 |
Device Name |
MINIMAX OXYGENATION SYSTEM |
Applicant |
MEDTRONIC VASCULAR |
4633 E. LA PALMA AVE. |
ANAHEIM,
CA
92807
|
|
Applicant Contact |
NORMA L LOWE |
Correspondent |
MEDTRONIC VASCULAR |
4633 E. LA PALMA AVE. |
ANAHEIM,
CA
92807
|
|
Correspondent Contact |
NORMA L LOWE |
Regulation Number | 870.4350
|
Classification Product Code |
|
Date Received | 06/17/1991 |
Decision Date | 09/13/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|