510(k) K233680
- Device
- Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT); Celect Platinum Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-CELECT-PT); Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (IGTCFS-65-1-UNI-CELECT-PT); Günther Tulip Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-TULIP); Günther Tulip Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-TULIP); Günther Tulip Vena Cava Filter
- Applicant
- William Cook Europe Aps
- 510(k) number
- K233680
- Product code
- DTK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-01-18
- Date received
- 2023-11-16
- Regulation
- 870.3375
- Classification name
- Filter, Intravascular, Cardiovascular
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Mie Dyrholm
- Address
- Sandet 6, Bjaeverskov DK DK 4632 DK 4632
FDA Registration Numbers
- 3002807314
- 3004111573
- 1018233
- 3010383847
- 1313046
- 1625425
- 3005580113
- 3007156625
- 3013764800
- 3007080617
- 3009888344
- 3006082230
- 3009526575
- 1722746
- 2020394
- 9616099
- 1643817
- 1820334
- 1721686
- 1016427
- 3002808486
- 9612452
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code DTK
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242612 | Option ELITE Vena Cava Filter System (352506070E 352506100E) | Argon Medical Devices, Inc. | 2024-09-10 |
| K240578 | VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System | B.Braun Medical, Inc. | 2024-07-31 |
| K241507 | ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK) | Aln S.A.R.L. | 2024-06-26 |
| K240257 | Denali Vena Cava Filter System Femoral and Jugular/Subclavian Delivery Kit | Bd | 2024-02-29 |
| K211875 | Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filte Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach | William Cook Europe Aps | 2021-07-28 |
| K211874 | 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 | William Cook Europe Aps | 2021-07-28 |
| K181202 | Sentry IVC Filter | Novate Medical , Ltd. | 2018-06-06 |
| K173236 | Sentry IVC Filter | Novate Medical , Ltd. | 2018-02-22 |
| K172584 | Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach | William Cook Europe Aps | 2017-11-20 |
| K172557 | 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 | William Cook Europe Aps | 2017-11-20 |
| K163699 | ALN Optional Vena Cava Filter - Femoral Approach, ALN Optional Vena Cava Filter - Jugular Approach, ALN Optional Vena Cava Filter - Brachial Approach, ALN Optional Vena Cava Filter - Femoral Approach with Hook | Aln Implants Chirurgicaux | 2017-09-08 |
| K171712 | 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 | William Cook Europe Aps | 2017-08-07 |
| K162875 | Sentry IVC filter | Novate Medical , Ltd. | 2017-02-17 |
| K161218 | Gianturco-Roehm Birds Nest Vena Cava Filter | Cook Incorporated | 2016-07-22 |
| K160866 | Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit | C.R. Bard, Inc. | 2016-04-29 |