Panels › Cardiovascular › Product code DTK · Class 2
Filter, Intravascular, Cardiovascular
Regulation 870.3375
0510(k)s in 12 months (83 all time)
1recalls in 12 months (22 all time)
22recalls that name a 510(k)
Top companies in DTK
| Company | 510(k)s | Recalls |
|---|---|---|
| C.R. Bard, Inc. | 13 | 0 |
| William Cook Europe Aps | 12 | 0 |
| Boston Scientific Corp | 6 | 2 |
| Cook Medical Incorporated | 0 | 8 |
| Bard Peripheral Vascular | 2 | 5 |
| Cordis Corp. | 5 | 2 |
| Nitinol Medical Technologies, Inc. | 7 | 0 |
| Cook Incorporated | 6 | 0 |
| Aln Implants Chirurgicaux | 3 | 0 |
| Argon Medical Devices, Inc. | 1 | 2 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 24, 2025 | Argon Medical Devices, Inc Option"ELITE Vena Cava Filter System REF 352506070E
UDI-DI code: 00886333217151
The Option"ELITE Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placemen Open, Classified |
DTK | K133243 |
| Jul 27, 2023 | Argon Medical Devices, Inc Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly, CE 2797 Open, Classified |
DTK | K133243 |
| Feb 14, 2022 | Cook Medical Incorporated Cook Celect PlatinumVena Cava Filter Set
Catalog Number/GPN:
IGTCFS-65-1-FEM-CELECT-PT G34502;
IGTCFS-65-1-JUG-CELECT-PT G34309;
IGTCFS-65-1-UNI-CELECT-PT G34505; Terminated |
DTK | K211875 |
| Feb 14, 2022 | Cook Medical Incorporated Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach
Catalog Number/GPN:
IGTCFS-65-1-FEM-TULIP G52917;
IGTCFS-65-1-JUG-TULIP G52916;
IGTCFS-65-1-UNI-TULIP G52918 Terminated |
DTK | K211874 |
| Feb 25, 2019 | Cook Medical Incorporated Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-C ELECT-PT
Product Usage:
The Cook Celect Platinum Filter implant is intended for the Terminated |
DTK | K171712 |
| Feb 25, 2019 | Cook Medical Incorporated Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Catalog Number GTCFS-65-1-JUG-CELECT-PT
Product Usage:
The Cook Celect Platinum Filter implant is intended for the prevention of Terminated |
DTK | K171712 |
| Feb 25, 2019 | Cook Medical Incorporated Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-CELECT-PT
Product Usage:
The Cook Celect Platinum Filter implant is intended for the prevention of Terminated |
DTK | K171712 |
| Feb 25, 2019 | Cook Medical Incorporated Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-TULIP
Product Usage:
The Gunther Tulip Filter is intended for the prevention of recurrent pul Terminated |
DTK | K172557 |
| Feb 25, 2019 | Cook Medical Incorporated Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Catalog Number IGTCFS-65-1-JUG-TULIP
Product Usage:
The Gunther Tulip Filter implant is intended for the prevention of recurrent pulmona Terminated |
DTK | K172557 |
| Feb 25, 2019 | Cook Medical Incorporated Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-TU LIP
Product Usage:
The Gunther Tulip Filter implant is intended for the prevention of recurrent pulmon Terminated |
DTK | K172557 |
| Feb 9, 2016 | Bard Peripheral Vascular Inc Denali Filter-Femoral Delivery System
Product Code: DL900F/DL950F;
Indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava. Terminated |
DTK | K130366 |
| Feb 9, 2016 | Bard Peripheral Vascular Inc Denali Filter-Jugular/Subclavian Delivery System
Product Code: DL900J/DL950J;
Indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava. Terminated |
DTK | K130366 |
| Feb 1, 2016 | Bard Peripheral Vascular Inc Denali Filter-Jugular/Subclavian DL950J
Denali Filter-Femoral Delivery DL950F.
Intravascular filters. Terminated |
DTK | K130366 |
| Oct 25, 2013 | Cordis Corporation Cordis OPTEASE Vena Cava Filter
Is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the vena cava in the following situations: - Pulmonary thromb Terminated |
DTK | K091077 |
| Aug 7, 2013 | Cordis Corporation Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat. No.***466F220A and 466F220B***Vena Cava Filter and Introduction Kit***(BRITE TIP Catheter Sheath Introducer and Angiographic Vessel Terminated |
DTK | K034050 K091077 |
| Nov 24, 2007 | B. Braun Interventional Systems Vena Tech LP Vena Cava Filter System, Item No/REF. 05010024, Model No: 40DLP, B Braun. Manufacturer: B. Braun Medical 204, avenue du Marechal Juin BP 331 92107 Boulogne Cedex , France. (The VenaTech L Terminated |
DTK | K010485 K063217 |
| May 10, 2007 | Boston Scientific Boston Scientific Medi-Tech Stainless Steel Greenfield Vena Cava Filter, order #50-400, lot #7826572 Terminated |
DTK | K964284 |
| Feb 1, 2007 | Bard Peripheral Vascular Inc Recovery G2 Filter System - Jugular/Subclavian Delivery Kit, for use in the prevention of recurrent pulmonary embolism. Catalog Number RF-220J ***For Canada & Australia only*** Terminated |
DTK | K052578 |
| Feb 1, 2007 | Bard Peripheral Vascular Inc G2 Filter System - Jugular/Subclavian Delivery Kit, for use in the prevention of recurrent pulmonary embolism. Catalog Number RF-320J Terminated |
DTK | K052578 |
| Dec 23, 2005 | Boston Scientific Scimed Titanium Greenfield Vena Cava Filter with 12 Fr./4,0 mm Introducer System. Catalog no. M001503010. Sterile EO. Single Use Only. Manufacturer: Boston Scientific Cork Ltd., Business and Technology Terminated |
DTK | K901659 |
| Dec 23, 2005 | Boston Scientific Scimed Stainless Steel Greenfield Vena Cava Filter with 12 Fr. / 4,0 mm FlexCarrier Capsule. Catalog no. M001505010. Sterile EO. Single Use Only. Manufacturer: Boston Scientific Cork Ltd., Business and Terminated |
DTK | K964284 |
| Dec 20, 2005 | Boston Scientific Stainless Steel Greenfield Vena Cava Filter with 12 Fr / 4,0 mm FlexCarrier Capsule. For Femoral Vein Introduction Only. Order No. 50-501. Sterile EO. Single Use Only. Read Instructions for Use Terminated |
DTK | K964284 |
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