Device Classification Name |
Filter, Intravascular, Cardiovascular
|
510(k) Number |
K090140 |
Device Name |
GUNTHER TULIP VENA CAVA FILTER, COOK CELECT VENA CAVA FILTER |
Applicant |
WILLIAM COOK EUROPE APS |
750 DANIELS WAY |
P.O. BOX 489 |
BLOOMINGTON,
IN
47402 -0489
|
|
Applicant Contact |
MOLLY BUSENBARK |
Correspondent |
WILLIAM COOK EUROPE APS |
750 DANIELS WAY |
P.O. BOX 489 |
BLOOMINGTON,
IN
47402 -0489
|
|
Correspondent Contact |
MOLLY BUSENBARK |
Regulation Number | 870.3375
|
Classification Product Code |
|
Date Received | 01/21/2009 |
Decision Date | 04/03/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Clinical Trials |
NCT00196118
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|