DTK · Class II · 21 CFR 870.3375

FDA Product Code DTK: Filter, Intravascular, Cardiovascular

Leading manufacturers include C.R. Bard, Inc., Boston Scientific Corp and Cordis Corp..

83
Total
83
Cleared
145d
Avg days
1976
Since
Declining activity - 2 submissions in the last 2 years vs 3 in the prior period
Review times improving: avg 80d recently vs 147d historically

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 Apr 29, 2016
Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit
K160866
C.R. Bard, Inc.
Cardiovascular · 30d
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 May 15, 2013
BARD DENALI FILTER SYSTEM- FEMORAL DELIVERY KIT AND JUGULAR DELIVERY KIT
K130366
C.R. Bard, Inc.
Cardiovascular · 91d
Cleared Oct 24, 2011
MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KIT
K112497
C.R. Bard, Inc.
Cardiovascular · 56d
Cleared Aug 24, 2011
MERIDAN FILTER SYSTEM- JUNGULAR/SUBECLAVIAN DELIVERY KIT
K102511
C.R. Bard, Inc.
Cardiovascular · 357d
Cleared Jun 25, 2010
ECLIPSE FILTER SYSTEM-FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS
K101431
C.R. Bard, Inc.
Cardiovascular · 35d
Cleared Jan 14, 2010
ECLIPSE FILTER SYSTEM-FEMORAL DELIVERY KIT, ECLIPSE FILTER SYSTEM-JUGULAR/SUBCLAVIAN DELIVERY KIT MODEL RF500F MODEL RF5
K093659
C.R. Bard, Inc.
Cardiovascular · 50d
Cleared Oct 31, 2008
G2 EXPRESS FILTER SYSTEM - FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS
K082305
C.R. Bard, Inc.
Cardiovascular · 79d
Cleared Jul 30, 2008
G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400F) AND JUGULAR/SUBCLAVIAN (RF400J) DELIVERY KITS
K080668
C.R. Bard, Inc.
Cardiovascular · 142d
Cleared Jan 15, 2008
RECOVERY G2 FILTER SYSTEM - FEMORAL DELIVERY KIT, MODEL RF-310F
K073090
C.R. Bard, Inc.
Cardiovascular · 75d
Cleared Aug 29, 2005
MODIFICATION TO: RECOVERY FILTER SYSTEM, MODEL RF-210F
K050558
C.R. Bard, Inc.
Cardiovascular · 179d
Cleared Jul 25, 2003
RECOVERY FILTER SYSTEM, MODEL RF-048F
K031328
C.R. Bard, Inc.
Cardiovascular · 88d
Cleared Nov 27, 2002
RECOVERY FILTER SYSTEM, MODEL RF-048F
K022236
C.R. Bard, Inc.
Cardiovascular · 139d
Cleared Oct 18, 2002
CORDIS OPTEASE PERMANENT VENA CAVA FILTER, MODELS 466-F200A, 466-F200B
K023116
Cordis Corp.
Cardiovascular · 29d
Cleared Jun 06, 2001
TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT, MODEL 466-P306A
K010083
Cordis Corp.
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 - 2 submissions in the last 24 months compared to 3 in the prior period.

FDA 510(k) Review Time - DTK Product Code

Recent submissions under DTK have taken an average of 80 days to reach a decision - down from 147 days historically, suggesting improved FDA processing for this classification.

DTK devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →