Device Classification Name |
console, heart-lung machine, cardiopulmonary bypass
|
510(k) Number |
K964017 |
Device Name |
AFFINITY BLOOD PUMP SYSTEM |
Applicant |
AVECOR CARDIOVASCULAR, INC. |
13010 COUNTRY RD. 6 |
PLYMOUTH,
MN
55441
|
|
Applicant Contact |
DENNIS E STEGER |
Correspondent |
AVECOR CARDIOVASCULAR, INC. |
13010 COUNTRY RD. 6 |
PLYMOUTH,
MN
55441
|
|
Correspondent Contact |
DENNIS E STEGER |
Regulation Number | 870.4220
|
Classification Product Code |
|
Date Received | 10/07/1996 |
Decision Date | 08/05/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|