Device Classification Name |
filter, intravascular, cardiovascular
|
510(k) Number |
K112119 |
Device Name |
CUNTHER TULIP(R) VENA CAVA FILTER SET FOR FEMORAL APPROACH, COOK CELECT(R) VENA CAVA FILTER FOR FEMORAL APPROACH |
Applicant |
WILLIAM COOK EUROPE APS |
ONE GEDDES WAY |
WEST LAFAYETTE,
IN
47906
|
|
Applicant Contact |
Jennifer Brown |
Correspondent |
WILLIAM COOK EUROPE APS |
ONE GEDDES WAY |
WEST LAFAYETTE,
IN
47906
|
|
Correspondent Contact |
Jennifer Brown |
Regulation Number | 870.3375
|
Classification Product Code |
|
Date Received | 07/25/2011 |
Decision Date | 03/30/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|