Device Classification Name |
filter, intravascular, cardiovascular
|
510(k) Number |
K171712 |
Device Name |
Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach |
Applicant |
William Cook Europe ApS |
Sandet 6 |
Bjaeverskov,
DK
4632
|
|
Applicant Contact |
Henriette Stordal Christiansen |
Correspondent |
William Cook Europe ApS |
Sandet 6 |
Bjaeverskov,
DK
4632
|
|
Correspondent Contact |
Henriette Stordal Christiansen |
Regulation Number | 870.3375
|
Classification Product Code |
|
Date Received | 06/09/2017 |
Decision Date | 08/07/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT00470626
|
Reviewed by Third Party |
No
|
Combination Product |
No
|