Gunther Tulip Vena Cava Filter Set
FDA 510(k) K043509 · Cook, Inc.
510(k) numberK043509
Submission
- Device name
- Gunther Tulip Vena Cava Filter Set
- Applicant
- Cook, Inc.
Bloomington, IN, US - Received
- December 20, 2004
- Decision date
- May 5, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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|---|---|---|---|
| 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 |
| K233680 | Celect Platinum Vena Cava Filter Set for Femoral Vein Approach…DTK · Traditional | William Cook Europe Aps | 01/18/2024SE |
| 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 |
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Questions and answers
When was Gunther Tulip Vena Cava Filter Set cleared by the FDA?
Gunther Tulip Vena Cava Filter Set (K043509) received a 510(k) decision of Substantially Equivalent on May 5, 2005, 136 days after the submission was received.
What is the product code of K043509?
The FDA product code is DTK – Filter, Intravascular, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.3375.