The following data is part of a premarket notification filed by William Cook Europe Aps with the FDA for Gunther Tulip Vena Cava Filter Set For Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set For Jugular Vein Approach, Gunther Tulip Vena Cava Filter Set For Femoral And Jugular Vein Approach.
| Device ID | K172557 |
| 510k Number | K172557 |
| Device Name: | Gunther Tulip Vena Cava Filter Set For Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set For Jugular Vein Approach, Gunther 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 | Henriette Stordal Christiansen |
| Correspondent | Henriette Stordal Christiansen William Cook Europe ApS Sandet 6 Bjaeverskov, DK 4632 |
| Product Code | DTK |
| CFR Regulation Number | 870.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-24 |
| Decision Date | 2017-11-20 |
| Summary: | summary |