Device Classification Name |
catheter, cannula and tubing, vascular, cardiopulmonary bypass
|
510(k) Number |
K093730 |
Device Name |
PORT ACCESS SYSTEMS ENDODIRECT ARTERIAL CANNULA MODEL ED24 (OLD CODE WAS-DFK24) |
Applicant |
EDWARDS LIFESCIENCES, LLC. |
6864 SOUTH 300 WEST |
MIDVALE,
UT
84047
|
|
Applicant Contact |
SPENCER WALKER |
Correspondent |
EDWARDS LIFESCIENCES, LLC. |
6864 SOUTH 300 WEST |
MIDVALE,
UT
84047
|
|
Correspondent Contact |
SPENCER WALKER |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 12/03/2009 |
Decision Date | 01/14/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|