Device Classification Name |
catheter, cannula and tubing, vascular, cardiopulmonary bypass
|
510(k) Number |
K924529 |
Device Name |
SIGNATURE(TM) CUSTOM TUBING PACK |
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 | 870.4210
|
Classification Product Code |
|
Date Received | 09/08/1992 |
Decision Date | 06/23/1993 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|