Device Classification Name |
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
More FDA Info for this Device |
510(K) Number |
K082139 |
Device Name |
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
Applicant |
EDWARDS LIFESCIENCES, LLC.
ONE EDWARDS WAY
IRVINE, CA 92614 US
Other 510(k) Applications for this Company
|
Contact |
DARYL RICHARDSON
Other 510(k) Applications for this Contact |
Regulation Number |
870.3470
More FDA Info for this Regulation Number |
Classification Product Code |
DXZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
07/29/2008 |
Decision Date |
10/23/2008 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
CV - Cardiovascular |
Review Advisory Committee |
CV - Cardiovascular |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|