Device Classification Name |
filter, intravascular, cardiovascular
|
510(k) Number |
K172584 |
Device Name |
Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip 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 | 08/28/2017 |
Decision Date | 11/20/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|