Device Classification Name |
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
|
510(k) Number |
K140208 |
Device Name |
FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM, AND FEM-FLEXII |
Applicant |
EDWARDS LIFESCIENCES, LLC. |
12050 Lone Peak Pkwy |
Draper,
UT
84020
|
|
Applicant Contact |
LINDSAY MARTIN |
Correspondent |
EDWARDS LIFESCIENCES, LLC. |
12050 Lone Peak Pkwy |
Draper,
UT
84020
|
|
Correspondent Contact |
LINDSAY MARTIN |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 01/28/2014 |
Decision Date | 03/05/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|