DTK · Filter, Intravascular, Cardiovascular
Cardiovascular · 21 CFR 870.3375 · Class 2
Overview
| Product Code | DTK |
|---|---|
| Device Name | Filter, Intravascular, Cardiovascular |
| Regulation | 21 CFR 870.3375 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| Implant | Yes |
Identification
A cardiovascular intravascular filter is an implant that is placed in the inferior vena cava for the purpose of preventing pulmonary thromboemboli (blood clots generated in the lower limbs and broken loose into the blood stream) from flowing into the right side of the heart and the pulmonary circulation.
Classification Rationale
Class II. The special controls for this device are:
Special Controls
*Classification.* Class II. The special controls for this device are:(1) “Use of International Standards Organization's ISO 10993 ‘Biological Evaluation of Medical Devices Part I: Evaluation and Testing,’ ” and (2) FDA's: (i) “510(k) Sterility Review Guidance and Revision of 2/12/90 (K90-1)” and (ii) “Guidance for Cardiovascular Intravascular Filter 510(k) Submissions.”
Recent Cleared Devices (20 of 84)
Showing 20 most recent of 84 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242612 | Option ELITE Vena Cava Filter System (352506070E 352506100E) | Argon Medical Devices, Inc. | Sep 10, 2024 | SESE |
| K240578 | VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System | B.Braun Medical, Inc. | Jul 31, 2024 | SESE |
| K241507 | ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK) | Aln S.A.R.L. | Jun 26, 2024 | SESE |
| K240257 | Denali Vena Cava Filter System Femoral and Jugular/Subclavian Delivery Kit | Bd | Feb 29, 2024 | SESE |
| K233680 | 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 | William Cook Europe Aps | Jan 18, 2024 | SESE |
| 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 | Jul 28, 2021 | SESE |
| 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 | Jul 28, 2021 | SESE |
| K181202 | Sentry IVC Filter | Novate Medical , Ltd. | Jun 6, 2018 | SESE |
| K173236 | Sentry IVC Filter | Novate Medical , Ltd. | Feb 22, 2018 | SESE |
| 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 | Nov 20, 2017 | SESE |
| 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 | Nov 20, 2017 | SESE |
| 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 | Sep 8, 2017 | SESE |
| 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 | Aug 7, 2017 | SESE |
| K162875 | Sentry IVC filter | Novate Medical , Ltd. | Feb 17, 2017 | SESE |
| K161218 | Gianturco-Roehm Birds Nest Vena Cava Filter | Cook Incorporated | Jul 22, 2016 | SESE |
| K160866 | Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit | C.R. Bard, Inc. | Apr 29, 2016 | SESE |
| K152765 | VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM | B. Braun Interventional Systems, Inc. | Feb 26, 2016 | SESE |
| K143405 | Option (TM) ELITE Vena Cava Filter 100cm System | Rex Medical, L.P. | Apr 16, 2015 | SESE |
| K150262 | Crux Vena Cava Filter System, femoral; Crux Vena Cava Filter System, jugular | Volcano Corporation | Apr 3, 2015 | SESE |
| K143208 | Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavain Delivery Kit | C.R. Bard, Inc. | Dec 9, 2014 | SESE |
Top Applicants
- C.R. Bard, Inc. — 13 clearances
- William Cook Europe Aps — 12 clearances
- Nitinol Medical Technologies, Inc. — 7 clearances
- Boston Scientific Corp — 6 clearances
- Cook, Inc. — 5 clearances
