Atlas FDA

DTK

83 FDA 510(k) clearances · Product code

87 daysmedian time to decision
332 days90th percentile
83clearances measured

FDA profile

Official device name
Filter, Intravascular, Cardiovascular
Device class
Class II (moderate risk)
Regulation
21 CFR 870.3375
Medical specialty
Cardiovascular
Flags
Implant
Adverse events (MAUDE)
2021: 5,357 · 2022: 2,191 · 2023: 583 · 2024: 406 · 2025: 438 · 2026: 225
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Option ELITE Vena Cava Filter System (352506070E 352506100E) (K242612)Argon Medical Devices, Inc.2024-09-10
VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System (K240578)B.Braun Medical, Inc.2024-07-31
ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK) (K241507)Aln S.A.R.L.2024-06-26
Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit (K240257)Bd2024-02-29
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 (K233680)William Cook Europe Aps2024-01-18
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 Aps2021-07-28
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 Aps2021-07-28
Sentry IVC Filter (K181202)Novate Medical , Ltd.2018-06-06
Sentry IVC Filter (K173236)Novate Medical , Ltd.2018-02-22
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 Aps2017-11-20
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 Aps2017-11-20
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 Chirurgicaux2017-09-08
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 Aps2017-08-07
Sentry IVC filter (K162875)Novate Medical , Ltd.2017-02-17
Gianturco-Roehm Bird’s Nest Vena Cava Filter (K161218)Cook Incorporated2016-07-22
Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit (K160866)C.R. Bard, Inc.2016-04-29
VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM (K152765)B. Braun Interventional Systems, Inc.2016-02-26
Option (TM) ELITE Vena Cava Filter 100cm System (K143405)Rex Medical, L.P.2015-04-16
Crux Vena Cava Filter System, femoral; Crux Vena Cava Filter System, jugular (K150262)Volcano Corporation2015-04-03
Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavain Delivery Kit (K143208)C.R. Bard, Inc.2014-12-09
OPTEASE VENA CAVA FILTER AND OPTEASE RETRIEVAL CATHTETER (K140286)Cordis, A Johnson & Johnson Co.2014-03-07
OPTION ELITE VENA CAVA FILTER SYSTEM (K133243)Rex Medical, L.P.2013-12-17
BARD DENALI FILTER SYSTEM- FEMORAL DELIVERY KIT AND JUGULAR DELIVERY KIT (K130366)C.R. Bard, Inc.2013-05-15
CRUX VENA CAVA FILTER SYSTEM (K122585)Crux Biomedical2013-01-17
ALN OPTIONAL VANA CAVA FILTER (K113124)Aln Implants Chirurgicaux2012-11-09
CRUX VENA CAVA FILTER SYSTEM (K120402)Crux Biomedical2012-07-13
COOK CELECT PLATINUM VENA CAVA FILTER SET FOR FEMORAL APPROACH COOK CELECT PLATIUM VENA CAVA FILTER SET FOR JUGULAR APPR (K121629)William Cook Europe Aps2012-07-03
COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS (K121057)William Cook Europe Aps2012-05-04
CUNTHER TULIP(R) VENA CAVA FILTER SET FOR FEMORAL APPROACH, COOK CELECT(R) VENA CAVA FILTER FOR FEMORAL APPROACH (K112119)William Cook Europe Aps2012-03-30
MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KIT (K112497)C.R. Bard, Inc.2011-10-24
MERIDAN FILTER SYSTEM- JUNGULAR/SUBECLAVIAN DELIVERY KIT (K102511)C.R. Bard, Inc.2011-08-24
ECLIPSE FILTER SYSTEM-FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS (K101431)C.R. Bard, Inc.2010-06-25
OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETER (K091077)Cordis Corp., A Johnson & Johnson Co.2010-02-04
ECLIPSE FILTER SYSTEM-FEMORAL DELIVERY KIT, ECLIPSE FILTER SYSTEM-JUGULAR/SUBCLAVIAN DELIVERY KIT MODEL RF500F MODEL RF5 (K093659)C.R. Bard, Inc.2010-01-14
OPTION VENA CAVA FILTER (K081410)Rex Medical2009-06-04
SAFEFLO VENA CAVA FILTER (K081138)Rmt Medical Technilogies, Inc.2009-05-07
GUNTHER TULIP VENA CAVA FILTER, COOK CELECT VENA CAVA FILTER (K090140)William Cook Europe Aps2009-04-03
G2 EXPRESS FILTER SYSTEM - FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS (K082305)C.R. Bard, Inc.2008-10-31
G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400F) AND JUGULAR/SUBCLAVIAN (RF400J) DELIVERY KITS (K080668)C.R. Bard, Inc.2008-07-30
COOK CLECT VENA CAVA FILTER, GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET (K073374)William Cook Europe Aps2008-03-07
VENA CAVA FILTER (K073528)Cook Incorporated2008-02-27
ALN OPTIONAL VENA CAVA FILTER-FEMORAL APPROACH, JUGULAR APPROACH, BRACHIAL APPROACH, EXTRACTION KIT, PRECURVED EXTRACTIO (K070514)Aln Implants Chirurgicaux2008-01-30
RECOVERY G2 FILTER SYSTEM - FEMORAL DELIVERY KIT, MODEL RF-310F; JUGULAR/SUBCLAVAIN DELIVERY KIT, MODEL RF-320J (K073090)C.R. Bard, Inc.2008-01-15
GUNTHER TULIP VENA CAVA FILTER (K072240)Cook, Inc.2007-11-08
COOK CELECT VENA CAVA FILTER (K061815)William Cook Europe Aps2007-04-20
VENATECH LP BRACHIAL INTRODUCER SYSTEM (ANTECUBITAL) (K063217)B.Braun Medical, Inc.2007-01-12
MODIFICATION TO G2 FILTER SYSTEM-FEMORAL DELIVERY KIT, MODEL RF-310F (K062887)Bard Peripheral Vascular2006-10-26
BARD G2 FILTER SYSTEM - JUGULAR/SUBCLAVIAN DELIVERY KIT, MODEL RF-320J (K052578)Bard Peripheral Vascular, Inc.2005-11-25
MODIFICATION TO: RECOVERY FILTER SYSTEM, MODEL RF-210F (K050558)C.R. Bard, Inc.2005-08-29
GUNTHER TULIP VENA CAVA FILTER SET (K043509)Cook, Inc.2005-05-05
CORDIS OPTEASE VENA CAVA FILTER, MODELS 466-F220A AND 466-F220B; RETRIEVABLE CATHETER, MODEL 466-C220F (K034050)Cordis Corporation2004-03-22
GUNHTER TULIP VENA CAVA MREYE FILTER AND RETRIEVAL SET (K032426)Cook, Inc.2003-10-31
RECOVERY FILTER SYSTEM, MODEL RF-048F (K031328)C.R. Bard, Inc.2003-07-25
RECOVERY FILTER SYSTEM, MODEL RF-048F (K022236)C.R. Bard, Inc.2002-11-27
CORDIS OPTEASE PERMANENT VENA CAVA FILTER, MODELS 466-F200A, 466-F200B (K023116)Cordis Corp.2002-10-18
TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT, MODEL 466-P306A (K010083)Cordis Corp.2001-06-06
VENA TECH VENA CAVA FILTER; VENA TECH 30D VENA CAVA FILTER; VENA TECH LP CAVE FILTER (K010485)Bbraun2001-05-18
TRAPEASE PERMANENT VENA FILTER AND INTRODUCTION KIT, MODELS 466-P306A AND 466-P306B (K003964)Cordis Corp.2001-01-19
GUNTHER TULIP VENA CAVA MREYE FILTER SET (K000855)Cook, Inc.2000-10-18
CORDIS TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT (K000062)Cordis Corp.2000-07-07
SIMON NITINOL FILTER/STRAIGHT LINE SYSTEM (K970099)Nitinol Medical Technologies, Inc.1997-04-16
STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F INTRODUCER SYSTEM (K964284)Boston Scientific Corp1997-01-06
SIMON NITINOL FILTER SYSTEM (K963016)Nitinol Medical Technologies, Inc.1996-11-18
SIMON NITINOL FILTER/STRAIGHT LINE SYSTEM (K963014)Nitinol Medical Technologies, Inc.1996-11-18
STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F FLEXCARRIER INTRODUCTER SYSTEM (K955396)Boston Scientific Corp1996-02-09
STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 24F INTRODUCER SYSTEM (K951508)Boston Scientific Corp1995-06-22
STAINLESS STEEL GREEN VENA CAVA FILT W/12F INTR SY (K912035)Boston Scientific Corp1995-06-15
SIMON NITINOL FILTER (K944353)Nitinol Medical Technologies, Inc.1995-04-28
SIMON NITINOL FILTER (K940489)Nitinol Medical Technologies, Inc.1994-08-09
PERCUTANEOUS INTRODUCER FOR VENA CAVA FILTER SYST (K932921)B. Braun Vena-Tech1993-08-30
VENA CAVA FILTER SYSTEMS, MODIFICATION (K925679)B. Braun Vena-Tech1992-11-27
SIMON NITINOL FILTER, MODIFICATION (K912144)Nitinol Medical Technologies, Inc.1991-10-17
VENA CAVA FILTER (K901454)Vena-Tech, Inc.1991-05-29
TITANIUM GREENFIELD(R) VENA CAVA FILTER W/HOOKS (K901659)Boston Scientific Corp1990-11-08
GREENFIELD VENA CAVA FILTER W/19.5 FR INTRODUCER (K901235)Boston Scientific Corp1990-10-09
SIMON NITINOL FILTER (K894703)Nitinol Medical Technologies, Inc.1990-04-20
VENA CAVA FILTER (K881604)Vena-Tech, Inc.1989-03-10
TITANIUM GREENFIELD VENA CAVA FILTER CARRIER (K874096)Medi-Tech, Inc.1988-11-04
TITANIUM PERCUTANEOUS GREENFIELD VENA CAVE FILTER (K870729)Medi-Tech, Inc.1987-04-09
PERCUTANEOUS GREENFIELD VENA CAVA FILTER SYSTEM (K852097)Medi-Tech, Inc.1985-11-01
VENA CAVA UMBRELLA FILTER, MODEL 7321 (K771046)Edwards Laboratories1977-06-22
APPLICATOR,ANGIOGRAPHY (7310MOBIN-UDDIN) (K760151)Edwards Laboratories1976-08-26
FILTER (7220&7221 MOBIN-UDDIN VENA CAVA) (K760152)Edwards Laboratories1976-07-19

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Every clearance here is in the API, with alerts when new ones post.