Device Classification Name |
filter, blood, cardiopulmonary bypass, arterial line
|
510(k) Number |
K022071 |
Device Name |
EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE,MODELS CF26000.CF29000,CF32000,CF35000,CF4000 |
Applicant |
EMBOL-X, INC. |
645 CLYDE AVE. |
MOUNTAIN VIEW,
CA
94043
|
|
Applicant Contact |
ED LEE |
Correspondent |
EMBOL-X, INC. |
645 CLYDE AVE. |
MOUNTAIN VIEW,
CA
94043
|
|
Correspondent Contact |
ED LEE |
Regulation Number | 870.4260
|
Classification Product Code |
|
Date Received | 06/26/2002 |
Decision Date | 02/14/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|