Device Classification Name |
Filter, Intravascular, Cardiovascular
|
510(k) Number |
K073374 |
Device Name |
COOK CLECT VENA CAVA FILTER, GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET |
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 | 12/03/2007 |
Decision Date | 03/07/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|