Device Classification Name |
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
|
510(k) Number |
K990396 |
Device Name |
T-ANASTAFLO |
Applicant |
EDWARDS LIFESCIENCES RESEARCH MEDICAL |
6864 SOUTH 300 WEST |
MIDVALE,
UT
84047
|
|
Applicant Contact |
JOHN W SMITH |
Correspondent |
EDWARDS LIFESCIENCES RESEARCH MEDICAL |
6864 SOUTH 300 WEST |
MIDVALE,
UT
84047
|
|
Correspondent Contact |
JOHN W SMITH |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 02/09/1999 |
Decision Date | 10/01/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|