Device Classification Name |
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
|
510(k) Number |
K033463 |
Device Name |
EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC ARTERIAL CANNULAE |
Applicant |
EDWARDS LIFESCIENCES LLC. |
ONE EDWARDS WAY |
IRVINE,
CA
92614
|
|
Applicant Contact |
JASON SMITH |
Correspondent |
EDWARDS LIFESCIENCES LLC. |
ONE EDWARDS WAY |
IRVINE,
CA
92614
|
|
Correspondent Contact |
JASON SMITH |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 10/31/2003 |
Decision Date | 07/28/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
Recalls |
CDRH Recalls
|
|
|