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 Fi
FDA 510(k) K233680 · William Cook Europe Aps
510(k) numberK233680
Submission
- Device name
- 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 Fi
- Applicant
- William Cook Europe Aps
Bjaeverskov, DK - Received
- November 16, 2023
- Decision date
- January 18, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DTK – Filter, Intravascular, Cardiovascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3375
- Specialty
- Cardiovascular
- Implant
- Yes
Other 510(k)s with product code DTK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242612 | Option ELITE Vena Cava Filter System (352506070E 352506100E)DTK · Special | Argon Medical Devices, Inc. | 09/10/2024SE |
| K240578 | VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter SystemDTK · Traditional | B.Braun Medical, Inc. | 07/31/2024SE |
| K241507 | ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)DTK · Special | Aln S.A.R.L. | 06/26/2024SE |
| K240257 | Denali Vena Cava Filter System Femoral and Jugular/Subclavian Delivery KitDTK · Special | Bd | 02/29/2024SE |
| K211875 | Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect…DTK · Special | William Cook Europe Aps | 07/28/2021SE |
| K211874 | Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava…DTK · Special | William Cook Europe Aps | 07/28/2021SE |
| K181202 | Sentry IVC FilterDTK · Special | Novate Medical , Ltd. | 06/06/2018SE |
| K173236 | Sentry IVC FilterDTK · Traditional | Novate Medical , Ltd. | 02/22/2018SE |
| K172584 | Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava…DTK · Traditional | William Cook Europe Aps | 11/20/2017SE |
| K172557 | Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava…DTK · Traditional | William Cook Europe Aps | 11/20/2017SE |
More from William Cook Europe Aps
| 510(k) | Device | Decision |
|---|---|---|
| K251596 | Lunderquist Extra Stiff Wire GuideDQX · Special | 11/09/2025SE |
| K251499 | Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer…BTR · Special | 06/11/2025SE |
| K220137 | Lunderquist Extra Stiff Wire GuideDQX · Special | 02/17/2022SE |
| K211875 | Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect…DTK · Special | 07/28/2021SE |
| K211874 | Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava…DTK · Special | 07/28/2021SE |
| K171513 | Lunderquist Extra Stiff Wire GuideDQX · Traditional | 12/07/2017SE |
| K172584 | Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava…DTK · Traditional | 11/20/2017SE |
| K172557 | Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava…DTK · Traditional | 11/20/2017SE |
| K171712 | Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect…DTK · Traditional | 08/07/2017SE |
| K161813 | Frova Intubating IntroducerBTR · Traditional | 05/19/2017SE |
Questions and answers
When was 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 Fi cleared by the FDA?
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 Fi (K233680) received a 510(k) decision of Substantially Equivalent on January 18, 2024, 63 days after the submission was received.
What is the product code of K233680?
The FDA product code is DTK – Filter, Intravascular, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.3375.