DTK · Class II · 21 CFR 870.3375

FDA Product Code DTK: Filter, Intravascular, Cardiovascular

Leading manufacturers include C.R. Bard, Inc., William Cook Europe Aps and Boston Scientific Corp.

83
Total
83
Cleared
145d
Avg days
1976
Since
Declining activity - 0 submissions in the last 2 years vs 5 in the prior period

FDA 510(k) Cleared Filter, Intravascular, Cardiovascular Devices (Product Code DTK)

83 devices
1–24 of 83
Cleared Sep 10, 2024
Option ELITE Vena Cava Filter System (352506070E 352506100E)
K242612
Argon Medical Devices, Inc.
Cardiovascular · 7d
Cleared Jul 31, 2024
VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System
K240578
B.Braun Medical, Inc.
Cardiovascular · 152d
Cleared Jun 26, 2024
ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)
K241507
Aln S.A.R.L.
Cardiovascular · 29d
Cleared Feb 29, 2024
Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit
K240257
Bd
Cardiovascular · 29d
Cleared Jan 18, 2024
Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT)
K233680
William Cook Europe Aps
Cardiovascular · 63d
Cleared Jul 28, 2021
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
K211874
William Cook Europe Aps
Cardiovascular · 41d
Cleared Jul 28, 2021
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
K211875
William Cook Europe Aps
Cardiovascular · 41d
Cleared Jun 06, 2018
Sentry IVC Filter
K181202
Novate Medical , Ltd.
Cardiovascular · 30d
Cleared Feb 22, 2018
Sentry IVC Filter
K173236
Novate Medical , Ltd.
Cardiovascular · 140d
Cleared Nov 20, 2017
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
K172557
William Cook Europe Aps
Cardiovascular · 88d
Cleared Nov 20, 2017
Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach
K172584
William Cook Europe Aps
Cardiovascular · 84d
Cleared Sep 08, 2017
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
K163699
Aln Implants Chirurgicaux
Cardiovascular · 253d
Cleared Aug 07, 2017
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
K171712
William Cook Europe Aps
Cardiovascular · 59d
Cleared Feb 17, 2017
Sentry IVC filter
K162875
Novate Medical , Ltd.
Cardiovascular · 126d
Cleared Jul 22, 2016
Gianturco-Roehm Bird’s Nest Vena Cava Filter
K161218
Cook Incorporated
Cardiovascular · 84d
Cleared Apr 29, 2016
Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit
K160866
C.R. Bard, Inc.
Cardiovascular · 30d
Cleared Feb 26, 2016
VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM
K152765
B. Braun Interventional Systems, Inc.
Cardiovascular · 155d
Cleared Apr 16, 2015
Option (TM) ELITE Vena Cava Filter 100cm System
K143405
Rex Medical, L.P.
Cardiovascular · 139d
Cleared Apr 03, 2015
Crux Vena Cava Filter System, femoral
K150262
Volcano Corporation
Cardiovascular · 58d
Cleared Dec 09, 2014
Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavain Delivery Kit
K143208
C.R. Bard, Inc.
Cardiovascular · 29d
Cleared Mar 07, 2014
OPTEASE VENA CAVA FILTER AND OPTEASE RETRIEVAL CATHTETER
K140286
Cordis, A Johnson & Johnson Co.
Cardiovascular · 30d
Cleared Dec 17, 2013
OPTION ELITE VENA CAVA FILTER SYSTEM
K133243
Rex Medical, L.P.
Cardiovascular · 56d
Cleared May 15, 2013
BARD DENALI FILTER SYSTEM- FEMORAL DELIVERY KIT AND JUGULAR DELIVERY KIT
K130366
C.R. Bard, Inc.
Cardiovascular · 91d
Cleared Jan 17, 2013
CRUX VENA CAVA FILTER SYSTEM
K122585
Crux Biomedical
Cardiovascular · 146d

About Product Code DTK - Regulatory Context

510(k) Submission Activity

83 total 510(k) submissions under product code DTK since 1976, with 83 receiving FDA clearance (average review time: 145 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 5 in the prior period.