Device Classification Name |
catheter, intravascular, diagnostic
|
510(k) Number |
K915726 |
Device Name |
PULMONARY ARTERY FLOW-DIRECTED THERMODILUTION CATH |
Applicant |
BAXTER HEALTHCARE CORP. |
P.O. BOX 11150 |
SANTA ANA,
CA
92711
|
|
Applicant Contact |
NANCY E SHADFORTH |
Correspondent |
BAXTER HEALTHCARE CORP. |
P.O. BOX 11150 |
SANTA ANA,
CA
92711
|
|
Correspondent Contact |
NANCY E SHADFORTH |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 12/20/1991 |
Decision Date | 09/21/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|