Device Classification Name |
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
|
510(k) Number |
K082139 |
Device Name |
EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700 |
Applicant |
EDWARDS LIFESCIENCES, LLC. |
ONE EDWARDS WAY |
IRVINE,
CA
92614
|
|
Applicant Contact |
DARYL RICHARDSON |
Correspondent |
EDWARDS LIFESCIENCES, LLC. |
ONE EDWARDS WAY |
IRVINE,
CA
92614
|
|
Correspondent Contact |
DARYL RICHARDSON |
Regulation Number | 870.3470
|
Classification Product Code |
|
Date Received | 07/29/2008 |
Decision Date | 10/23/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|