Device Classification Name |
catheter, flow directed
|
510(k) Number |
K934742 |
Device Name |
SWAN-GANZ CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS PORT |
Applicant |
BAXTER HEALTHCARE CORP. |
P.O. BOX 11150 |
SANTA ANA,
CA
92711
|
|
Applicant Contact |
IRENE PONZOA PARKER |
Correspondent |
BAXTER HEALTHCARE CORP. |
P.O. BOX 11150 |
SANTA ANA,
CA
92711
|
|
Correspondent Contact |
IRENE PONZOA PARKER |
Regulation Number | 870.1240
|
Classification Product Code |
|
Date Received | 10/04/1993 |
Decision Date | 01/24/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|