The following data is part of a premarket notification filed by William Cook Europe Aps with the FDA for 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.
| Device ID | K211874 |
| 510k 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 |
| Classification | Filter, Intravascular, Cardiovascular |
| Applicant | William Cook Europe ApS Sandet 6 Bjaeverskov, DK 4632 |
| Contact | Mie Dyrholm |
| Correspondent | Mie Dyrholm William Cook Europe ApS Sandet 6 Bjaeverskov, DK 4632 |
| Product Code | DTK |
| CFR Regulation Number | 870.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-17 |
| Decision Date | 2021-07-28 |