Filter, Intravascular, Cardiovascular
FDA product code DTK · Class II (moderate risk) · 21 CFR 870.3375 · Cardiovascular
83510(k) clearances
1PMA approvals
19recalls
Implantimplanted device
Manufacturers
- C.R. Bard, Inc. 13
- William Cook Europe Aps 12
- Nitinol Medical Technologies, Inc. 7
- Boston Scientific Corporation 6
- Cook, Inc. 6
- Cordis Corp. 5
- Medi-Tech, Inc. 3
- Novate Medical , Ltd. 3
- Aln Implants Chirurgicaux 3
- Edwards Laboratories 3
- Bard Peripheral Vascular Inc 2
- B. Braun Medical, Inc. 2
- B. Braun Vena-Tech 2
- Vena-Tech, Inc. 2
- Crux Biomedical 2
- Rex Medical, L.P. 2
- Bbraun 1
- Rmt Medical Technilogies, Inc. 1
- Rex Medical 1
- Cordis Corp., A Johnson & Johnson Co. 1
510(k) clearances
| 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 |
| 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 |
| K172557 | Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava…DTK · Traditional | William Cook Europe Aps | 11/20/2017SE |
| K163699 | ALN Optional Vena Cava Filter - Femoral Approach, ALN Optional Vena Cava Filter -…DTK · Abbreviated | Aln Implants Chirurgicaux | 09/08/2017SE |
| K171712 | Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect…DTK · Traditional | William Cook Europe Aps | 08/07/2017SE |
| K162875 | Sentry IVC filterDTK · Traditional | Novate Medical , Ltd. | 02/17/2017SE |
| K161218 | Gianturco-Roehm Birds Nest Vena Cava FilterDTK · Traditional | Cook Incorporated | 07/22/2016SE |
| K160866 | Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian…DTK · Special | C.R. Bard, Inc. | 04/29/2016SE |
| K152765 | Venatech Convertible Vena Cava Filter SystemDTK · Traditional | B. Braun Interventional Systems, Inc. | 02/26/2016SE |
| K143405 | Option (TM) ELITE Vena Cava Filter 100cm SystemDTK · Traditional | Rex Medical, L.P. | 04/16/2015SE |
| K150262 | Crux Vena Cava Filter System, femoral; Crux Vena Cava Filter System, jugularDTK · Traditional | Volcano Corporation | 04/03/2015SE |
| K143208 | Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavain…DTK · Special | C.R. Bard, Inc. | 12/09/2014SE |
| K140286 | Optease Vena Cava Filter and Optease Retrieval CathteterDTK · Special | Cordis, A Johnson & Johnson Co. | 03/07/2014SE |
| K133243 | Option Elite Vena Cava Filter SystemDTK · Traditional | Rex Medical, L.P. | 12/17/2013SE |
| K130366 | Bard Denali Filter System- Femoral Delivery Kit and Jugular Delivery KitDTK · Traditional | C.R. Bard, Inc. | 05/15/2013SE |
| K122585 | Crux Vena Cava Filter SystemDTK · Special | Crux Biomedical | 01/17/2013SE |
| K113124 | Aln Optional Vana Cava FilterDTK · Abbreviated | Aln Implants Chirurgicaux | 11/09/2012SE |
| K120402 | Crux Vena Cava Filter SystemDTK · Traditional | Crux Biomedical | 07/13/2012SE |
| K121629 | Cook Celect Platinum Vena Cava Filter Set for Femoral Approach Cook Celect Platium Vena…DTK · Traditional | William Cook Europe Aps | 07/03/2012SE |
| K121057 | Cook Celect and Gunther Tulip Vena Cava Filter SetsDTK · Special | William Cook Europe Aps | 05/04/2012SE |
| K112119 | Cunther Tulip(R) Vena Cava Filter Set for Femoral Approach, Cook Celect(R) Vena Cava…DTK · Traditional | William Cook Europe Aps | 03/30/2012SE |
| K112497 | Meridian Filter System - Femoral Delivery KitDTK · Special | C.R. Bard, Inc. | 10/24/2011SE |
| K102511 | Meridan Filter System- Jungular/Subeclavian Delivery KitDTK · Traditional | C.R. Bard, Inc. | 08/24/2011SE |
| K101431 | Eclipse Filter System-Femoral and Jugular/Subclavian Delivery KitsDTK · Special | C.R. Bard, Inc. | 06/25/2010SE |
| K091077 | Optease Vena Cava Filter and Retrieval CatheterDTK · Special | Cordis Corp., A Johnson & Johnson Co. | 02/04/2010SE |
| K093659 | Eclipse Filter System-Femoral Delivery Kit, Eclipse Filter System-Jugular/Subclavian…DTK · Special | C.R. Bard, Inc. | 01/14/2010SE |
| K081410 | Option Vena Cava FilterDTK · Traditional | Rex Medical | 06/04/2009SE |
| K081138 | Safeflo Vena Cava FilterDTK · Traditional | Rmt Medical Technilogies, Inc. | 05/07/2009SESU |
| K090140 | Gunther Tulip Vena Cava Filter, Cook Celect Vena Cava FilterDTK · Special | William Cook Europe Aps | 04/03/2009SE |
| K082305 | G2 Express Filter System - Femoral and Jugular/Subclavian Delivery KitsDTK · Special | C.R. Bard, Inc. | 10/31/2008SE |
| K080668 | G2 Express Filter System-Femoral (RF400F) and Jugular/Subclavian (RF400J) Delivery KitsDTK · Special | C.R. Bard, Inc. | 07/30/2008SE |
| K073374 | Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval SetDTK · Traditional | William Cook Europe Aps | 03/07/2008SE |
| K073528 | Vena Cava FilterDTK · Special | Cook Incorporated | 02/27/2008SE |
| K070514 | Aln Optional Vena Cava Filter-Femoral Approach, Jugular Approach, Brachial Approach…DTK · Abbreviated | Aln Implants Chirurgicaux | 01/30/2008SE |
| K073090 | Recovery G2 Filter System - Femoral Delivery Kit, Model RF-310F; Jugular/Subclavain…DTK · Traditional | C.R. Bard, Inc. | 01/15/2008SE |
| K072240 | Gunther Tulip Vena Cava FilterDTK · Special | Cook, Inc. | 11/08/2007SE |
| K061815 | Cook Celect Vena Cava FilterDTK · Traditional | William Cook Europe Aps | 04/20/2007SE |
| K063217 | Venatech LP Brachial Introducer System (Antecubital)DTK · Traditional | B.Braun Medical, Inc. | 01/12/2007SE |
| K062887 | Modification to G2 Filter System-Femoral Delivery Kit, Model RF-310FDTK · Special | Bard Peripheral Vascular | 10/26/2006SE |
| K052578 | Bard G2 Filter System - Jugular/Subclavian Delivery Kit, Model RF-320JDTK · Special | Bard Peripheral Vascular, Inc. | 11/25/2005SESU |
| K050558 | Modification to: Recovery Filter System, Model RF-210FDTK · Traditional | C.R. Bard, Inc. | 08/29/2005SESU |
| K043509 | Gunther Tulip Vena Cava Filter SetDTK · Special | Cook, Inc. | 05/05/2005SE |
| K034050 | Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable Catheter…DTK · Traditional | Cordis Corporation | 03/22/2004SE |
| K032426 | Gunhter Tulip Vena Cava Mreye Filter and Retrieval SetDTK · Traditional | Cook, Inc. | 10/31/2003SE |
| K031328 | Recovery Filter System, Model RF-048FDTK · Abbreviated | C.R. Bard, Inc. | 07/25/2003SE |
| K022236 | Recovery Filter System, Model RF-048FDTK · Special | C.R. Bard, Inc. | 11/27/2002SE |
| K023116 | Cordis Optease Permanent Vena Cava Filter, Models 466-F200A, 466-F200BDTK · Special | Cordis Corp. | 10/18/2002SESU |
| K010083 | Trapease Permanent Vena Cava Filter and Introduction Kit, Model 466-P306ADTK · Traditional | Cordis Corp. | 06/06/2001SE |
| K010485 | Vena Tech Vena Cava Filter; Vena Tech 30D Vena Cava Filter; Vena Tech LP Cave FilterDTK · Traditional | Bbraun | 05/18/2001SE |
| K003964 | Trapease Permanent Vena Filter and Introduction Kit, Models 466-P306A and 466-P306BDTK · Special | Cordis Corp. | 01/19/2001SE |
| K000855 | Gunther Tulip Vena Cava Mreye Filter SetDTK · Traditional | Cook, Inc. | 10/18/2000SE |
| K000062 | Cordis Trapease Permanent Vena Cava Filter and Introduction KitDTK · Traditional | Cordis Corp. | 07/07/2000SE |
| K970099 | Simon Nitinol Filter/Straight Line SystemDTK · Traditional | Nitinol Medical Technologies, Inc. | 04/16/1997SE |
| K964284 | Stainless Steel Greenfield Vena Cava Filter with 12F Introducer SystemDTK · Traditional | Boston Scientific Corp | 01/06/1997SE |
| K963016 | Simon Nitinol Filter SystemDTK · Traditional | Nitinol Medical Technologies, Inc. | 11/18/1996SE |
| K963014 | Simon Nitinol Filter/Straight Line SystemDTK · Traditional | Nitinol Medical Technologies, Inc. | 11/18/1996SE |
| K955396 | Stainless Steel Greenfield Vena Cava Filter with 12F Flexcarrier Introducter SystemDTK · Traditional | Boston Scientific Corp | 02/09/1996SE |
| K951508 | Stainless Steel Greenfield Vena Cava Filter with 24F Introducer SystemDTK · Traditional | Boston Scientific Corp | 06/22/1995SE |
| K912035 | Stainless Steel Green Vena Cava Filt W/12F Intr SyDTK · Traditional | Boston Scientific Corp | 06/15/1995SE |
| K944353 | Simon Nitinol FilterDTK · Traditional | Nitinol Medical Technologies, Inc. | 04/28/1995SE |
| K940489 | Simon Nitinol FilterDTK · Traditional | Nitinol Medical Technologies, Inc. | 08/09/1994SE |
| K932921 | Percutaneous Introducer for Vena Cava Filter SystDTK · Traditional | B. Braun Vena-Tech | 08/30/1993SE |
| K925679 | Vena Cava Filter Systems, ModificationDTK · Traditional | B. Braun Vena-Tech | 11/27/1992SE |
| K912144 | Simon Nitinol Filter, ModificationDTK · Traditional | Nitinol Medical Technologies, Inc. | 10/17/1991SE |
| K901454 | Vena Cava FilterDTK · Traditional | Vena-Tech, Inc. | 05/29/1991SE |
| K901659 | Titanium Greenfield(R) Vena Cava Filter W/HooksDTK · Traditional | Boston Scientific Corp | 11/08/1990SE |
| K901235 | Greenfield Vena Cava Filter W/19.5 FR IntroducerDTK · Traditional | Boston Scientific Corp | 10/09/1990SE |
| K894703 | Simon Nitinol FilterDTK · Traditional | Nitinol Medical Technologies, Inc. | 04/20/1990SE |
| K881604 | Vena Cava FilterDTK · Traditional | Vena-Tech, Inc. | 03/10/1989SE |
| K874096 | Titanium Greenfield Vena Cava Filter CarrierDTK · Traditional | Medi-Tech, Inc. | 11/04/1988SE |
| K870729 | Titanium Percutaneous Greenfield Vena Cave FilterDTK · Traditional | Medi-Tech, Inc. | 04/09/1987SE |
| K852097 | Percutaneous Greenfield Vena Cava Filter SystemDTK · Traditional | Medi-Tech, Inc. | 11/01/1985SE |
| K771046 | Vena Cava Umbrella Filter, Model 7321DTK · Traditional | Edwards Laboratories | 06/22/1977SE |
| K760151 | Applicator,Angiography (7310MOBIN-UDDIN)DTK · Traditional | Edwards Laboratories | 08/26/1976SE |
| K760152 | Filter (7220&7221 Mobin-Uddin Vena Cava)DTK · Traditional | Edwards Laboratories | 07/19/1976SE |
PMA approvals
- P850049 Cook Bird's Nest Vena Cava Filter · Cook, Inc. · 04/26/1989
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0589-2026 Class II | Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The…Due to complaints of increased resistance when advancing the dilator within the introducer sheath. This… | Argon Medical Devices, Inc | 09/12/2025Open, Classified |
| Z-2239-2023 Class II | Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter…There is the potential that the vena Cava Filter may not perform as intended which may result in pulmonary… | Argon Medical Devices, Inc | 06/08/2023Open, Classified |
| Z-0876-2022 Class III | Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN: IGTCFS-65-1-FEM-CELECT-PT…IFU update includes an update to the Device description, Intended Use/Indications for Use… | Cook Medical Incorporated | 02/14/2022Terminated |
| Z-0875-2022 Class III | Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN:…IFU update includes an update to the Device description, Intended Use/Indications for Use… | Cook Medical Incorporated | 02/14/2022Terminated |
| Z-1026-2019 Class III | Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog…Updates to the Instructions for Use. | Cook Medical Incorporated | 02/25/2019Terminated |
| Z-1025-2019 Class III | Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Catalog Number…Updates to the Instructions for Use. | Cook Medical Incorporated | 02/25/2019Terminated |
| Z-1024-2019 Class III | Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Catalog Number…Updates to the Instructions for Use. | Cook Medical Incorporated | 02/25/2019Terminated |
| Z-1023-2019 Class III | Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number…Updates to the Instructions for Use. | Cook Medical Incorporated | 02/25/2019Terminated |
| Z-1022-2019 Class III | Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Catalog Number…Updates to the Instructions for Use. | Cook Medical Incorporated | 02/25/2019Terminated |
| Z-1021-2019 Class III | Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Catalog Number…Updates to the Instructions for Use. | Cook Medical Incorporated | 02/25/2019Terminated |
| Z-1069-2016 Class II | Denali Filter-Femoral Delivery System Product Code: DL900F/DL950F; Indicated for use in…Bard Peripheral Vascular, Inc. is recalling Denali Filter-Jugular/Subclavian Delivery System and Denali… | Bard Peripheral Vascular Inc | 02/09/2016Terminated |
| Z-1068-2016 Class II | Denali Filter-Jugular/Subclavian Delivery System Product Code: DL900J/DL950J; Indicated…Bard Peripheral Vascular, Inc. is recalling Denali Filter-Jugular/Subclavian Delivery System and Denali… | Bard Peripheral Vascular Inc | 02/09/2016Terminated |
| Z-0737-2016 Class II | Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950F.…IFU missing contraindications: Patients with uncontrolled sepsis and Patients with known hypersensitivity to… | Bard Peripheral Vascular Inc | 03/13/2015Terminated |
| Z-0081-2014 Class II | Cordis OPTEASE Vena Cava Filter Is indicated for use in the prevention of recurrent…Cordis identified a printing error on one unit of the Optease Vena Cava Filter, in which the orientation… | Cordis Corporation | 09/27/2013Terminated |
| Z-1887-2013 Class I | Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat. No.***466F220A and…Correction to provide clarification and additional labeling to minimize likelihood on implanting filter… | Cordis Corporation | 03/29/2013Terminated |
| Z-0264-2008 | Vena Tech LP Vena Cava Filter System, Item No/REF. 05010024, Model No: 40DLP, B Braun.…Sterility (package integrity) compromised: package sealing problem leaving packaging being partially open on… | B. Braun Interventional Systems | 10/30/2007Terminated |
| Z-0394-2007 | Recovery G2 Filter System - Jugular/Subclavian Delivery Kit, for use in the prevention…This action is being taken because BPV has recently received three complaints for the device that involve… | Bard Peripheral Vascular Inc | 12/20/2006Terminated |
| Z-0393-2007 | G2 Filter System - Jugular/Subclavian Delivery Kit, for use in the prevention of…This action is being taken because BPV has recently received three complaints for the device that involve… | Bard Peripheral Vascular Inc | 12/20/2006Terminated |
| Z-0794-2007 | Boston Scientific Medi-Tech Stainless Steel Greenfield Vena Cava Filter, order #50-400…One lot of product, Stainless Steel Greenfield Vena Cava Filter, may have the incorrect expiration date of… | Boston Scientific | 10/06/2006Terminated |