Device Classification Name |
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
|
510(k) Number |
K953564 |
Device Name |
MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE |
Applicant |
MEDTRONIC CARDIAC SURGERY, MEDTRONIC, INC. |
4633 EAST LA PALMA AVE. |
ANAHEIM,
CA
92807
|
|
Applicant Contact |
WAYNE R HOHMAN |
Correspondent |
MEDTRONIC CARDIAC SURGERY, MEDTRONIC, INC. |
4633 EAST LA PALMA AVE. |
ANAHEIM,
CA
92807
|
|
Correspondent Contact |
WAYNE R HOHMAN |
Regulation Number | 870.4290
|
Classification Product Code |
|
Date Received | 07/31/1995 |
Decision Date | 02/02/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|