Device Classification Name |
Filter, Blood, Cardiopulmonary Bypass, Arterial Line
|
510(k) Number |
K062429 |
Device Name |
MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESH |
Applicant |
EDWARDS LIFESCIENCES RESEARCH MEDICAL |
6864 SOUTH 300 WEST |
MIDVALE,
UT
84047
|
|
Applicant Contact |
KAREN JONES |
Correspondent |
EDWARDS LIFESCIENCES RESEARCH MEDICAL |
6864 SOUTH 300 WEST |
MIDVALE,
UT
84047
|
|
Correspondent Contact |
KAREN JONES |
Regulation Number | 870.4260
|
Classification Product Code |
|
Date Received | 08/21/2006 |
Decision Date | 09/27/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|