Device Classification Name |
filter, intravascular, cardiovascular
|
510(k) Number |
K211874 |
Device Name |
Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular 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 |
Mie Dyrholm |
Correspondent |
William Cook Europe ApS |
Sandet 6 |
Bjaeverskov,
DK
4632
|
|
Correspondent Contact |
Mie Dyrholm |
Regulation Number | 870.3375
|
Classification Product Code |
|
Date Received | 06/17/2021 |
Decision Date | 07/28/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|