Product code DTK

Device name: Filter, Intravascular, Cardiovascular
Medical specialty: Cardiovascular
Device class: 2
Regulation number: 870.3375
Review panel: CV
Implant: Y
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

PMA, Device, Applicant table
PMA	Device	Applicant	Decision date
P850049S009	BIRD'S NEST VENA CAVA FILTER	Cook, Inc.	2006-02-03
P850049S008	GIANTURCO-ROEHM BIRD'S NEST(TM) VENA CAVA FILTER	Cook, Inc.	2002-02-13
P850049S007	GIANTURCO-ROEHM BIRD'S NEST VENA CAVA FILTER	Cook, Inc.	1999-09-14
P850049S006	GIANTURCO-ROEHM BIRD'S NEST VENA CAVA FILTER	Cook, Inc.	1998-12-21
P850049S005	COOK BIRD'S NEST VENA CAVA FILTER	Cook, Inc.	1996-09-17
P850049S004	COOK BIRD'S NEST VENA CAVA FILTER	Cook, Inc.	1994-08-09
P850049S003	COOK BIRD'S NEST VENA CAVA FILTER	Cook, Inc.	1993-09-23
P850049S001	COOK BIRD'S NEST VENA CAVA FILTER	Cook, Inc.	1992-12-08
P850049S002	COOK BIRD'S NEST VENA CAVA FILTER	Cook, Inc.	1991-05-02
P850049	COOK BIRD'S NEST VENA CAVA FILTER	Cook, Inc.	1989-04-26

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K242612	Option ELITE Vena Cava Filter System (352506070E 352506100E)	Argon Medical Devices, Inc.	2024-09-10
K240578	VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System	B.Braun Medical, Inc.	2024-07-31
K241507	ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)	Aln S.A.R.L.	2024-06-26
K240257	Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit	Bd	2024-02-29
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 ...	William Cook Europe Aps	2024-01-18
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	2021-07-28
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	2021-07-28
K181202	Sentry IVC Filter	Novate Medical , Ltd.	2018-06-06
K173236	Sentry IVC Filter	Novate Medical , Ltd.	2018-02-22
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	2017-11-20
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	2017-11-20
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	2017-09-08
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	2017-08-07
K162875	Sentry IVC filter	Novate Medical , Ltd.	2017-02-17
K161218	Gianturco-Roehm Bird’s Nest Vena Cava Filter	Cook Incorporated	2016-07-22
K160866	Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit	C.R. Bard, Inc.	2016-04-29
K152765	VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM	B. Braun Interventional Systems, Inc.	2016-02-26
K143405	Option (TM) ELITE Vena Cava Filter 100cm System	Rex Medical, L.P.	2015-04-16
K150262	Crux Vena Cava Filter System, femoral; Crux Vena Cava Filter System, jugular	Volcano Corporation	2015-04-03
K143208	Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavain Delivery Kit	C.R. Bard, Inc.	2014-12-09
K140286	OPTEASE VENA CAVA FILTER AND OPTEASE RETRIEVAL CATHTETER	Cordis, A Johnson & Johnson Co.	2014-03-07
K133243	OPTION ELITE VENA CAVA FILTER SYSTEM	Rex Medical, L.P.	2013-12-17
K130366	BARD DENALI FILTER SYSTEM- FEMORAL DELIVERY KIT AND JUGULAR DELIVERY KIT	C.R. Bard, Inc.	2013-05-15
K122585	CRUX VENA CAVA FILTER SYSTEM	Crux Biomedical	2013-01-17
K113124	ALN OPTIONAL VANA CAVA FILTER	Aln Implants Chirurgicaux	2012-11-09
K120402	CRUX VENA CAVA FILTER SYSTEM	Crux Biomedical	2012-07-13
K121629	COOK CELECT PLATINUM VENA CAVA FILTER SET FOR FEMORAL APPROACH COOK CELECT PLATIUM VENA CAVA FILTER SET FOR JUGULAR APPR	William Cook Europe Aps	2012-07-03
K121057	COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS	William Cook Europe Aps	2012-05-04
K112119	CUNTHER TULIP(R) VENA CAVA FILTER SET FOR FEMORAL APPROACH, COOK CELECT(R) VENA CAVA FILTER FOR FEMORAL APPROACH	William Cook Europe Aps	2012-03-30
K112497	MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KIT	C.R. Bard, Inc.	2011-10-24

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00886333217519	Option Elite Retrievable Vena Cava Filter	ARGON MEDICAL DEVICES, INC.	2019-07-26
03760017680127	ALN 2in1	A.L.N.	2018-10-26
03760017680110	ALN Pre-Curved RS	A.L.N.	2018-10-26
03760017680103	ALN Straight RS	A.L.N.	2018-10-26
03760017680066	ALN Optional Vena Cava Filter - Brachial Approach with Hook	A.L.N.	2018-10-26
03760017680059	ALN Optional Vena Cava Filter - Jugular Approach with Hook	A.L.N.	2018-10-26
03760017680042	ALN Optional Vena Cava Filter - Femoral Approach with Hook	A.L.N.	2018-10-26
03760017680028	ALN Optional Vena Cava Filter - Brachial Approach	A.L.N.	2018-10-26
03760017680011	ALN Optional Vena Cava Filter - Jugular Approach	A.L.N.	2018-10-26
03760017680004	ALN Optional Vena Cava Filter - Femoral Approach	A.L.N.	2018-10-26
05391529380069	Sentry IVC Filter	NOVATE MEDICAL LIMITED	2018-09-27
04046964332333	VENA TECH	B. BRAUN MEDICAL INC.	2017-01-18
08714729050650	Entry Kit	BOSTON SCIENTIFIC CORPORATION	2016-01-29
10827002355801	Cook Celect	William Cook Europe ApS	2015-12-07
10827002529141	Cook Celect	William Cook Europe ApS	2015-10-24
10827002529158	Cook Celect	William Cook Europe ApS	2015-10-24
10827002529097	Cook Celect	William Cook Europe ApS	2015-10-24
10827002355900	Cook Celect	William Cook Europe ApS	2015-10-24
10827002330174	Gunther Tulip	COOK INCORPORATED	2015-10-24
10827002330167	Gunther Tulip	COOK INCORPORATED	2015-10-24
10827002213606	Gunther Tulip	COOK INCORPORATED	2015-10-24
10827002037677	Cook Celect	William Cook Europe ApS	2015-10-24
10827002037660	Gunther Tulip	William Cook Europe ApS	2015-10-24
00827002483729	Cook Celect	William Cook Europe ApS	2015-10-24
00827002483736	Cook Celect	William Cook Europe ApS	2015-10-24
08714729070276	Greenfield™	BOSTON SCIENTIFIC CORPORATION	2015-09-24
08714729124993	Greenfield™	BOSTON SCIENTIFIC CORPORATION	2015-09-24
08714729114666	Greenfield™	BOSTON SCIENTIFIC CORPORATION	2015-09-24
08714729114659	Greenfield™	BOSTON SCIENTIFIC CORPORATION	2015-09-24
20705032009475	TrapEase Permanent Vena Cava Filter with the VisEase Angiographic Vessel Dilator	Cordis US Corp.	2015-08-28

Product code DTK

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