FDA 510(k) Applications for Medical Device Product Code "DTK"
(Filter, Intravascular, Cardiovascular)

FDA 510(k) Number Applicant Device Name Decision Date
K113124 ALN IMPLANTS CHIRURGICAUX ALN OPTIONAL VANA CAVA FILTER 11/09/2012
K163699 ALN Implants Chirurgicaux 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 09/08/2017
K070514 ALN IMPLANTS CHIRURGICAUX ALN OPTIONAL VENA CAVA FILTER-FEMORAL APPROACH, JUGULAR APPROACH, BRACHIAL APPROACH, EXTRACTION KIT, PRECURVED EXTRACTIO 01/30/2008
K010485 B BRAUN VENA TECH VENA CAVA FILTER; VENA TECH 30D VENA CAVA FILTER; VENA TECH LP CAVE FILTER 05/18/2001
K063217 B. BRAUN MEDICAL, INC. VENATECH LP BRACHIAL INTRODUCER SYSTEM (ANTECUBITAL) 01/12/2007
K932921 B. BRAUN VENA-TECH PERCUTANEOUS INTRODUCER FOR VENA CAVA FILTER SYST 08/30/1993
K925679 B. BRAUN VENA-TECH VENA CAVA FILTER SYSTEMS, MODIFICATION 11/27/1992
K152765 B.BRAUN INTERVENTIONAL SYSTEMS INC. VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM 02/26/2016
K062887 BARD PERIPHERAL VASCULAR MODIFICATION TO G2 FILTER SYSTEM-FEMORAL DELIVERY KIT, MODEL RF-310F 10/26/2006
K052578 BARD PERIPHERAL VASCULAR, INC. BARD G2 FILTER SYSTEM - JUGULAR/SUBCLAVIAN DELIVERY KIT, MODEL RF-320J 11/25/2005
K901235 BOSTON SCIENTIFIC CORP. GREENFIELD VENA CAVA FILTER W/19.5 FR INTRODUCER 10/09/1990
K912035 BOSTON SCIENTIFIC CORP. STAINLESS STEEL GREEN VENA CAVA FILT W/12F INTR SY 06/15/1995
K955396 BOSTON SCIENTIFIC CORP. STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F FLEXCARRIER INTRODUCTER SYSTEM 02/09/1996
K964284 BOSTON SCIENTIFIC CORP. STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F INTRODUCER SYSTEM 01/06/1997
K951508 BOSTON SCIENTIFIC CORP. STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 24F INTRODUCER SYSTEM 06/22/1995
K901659 BOSTON SCIENTIFIC CORP. TITANIUM GREENFIELD(R) VENA CAVA FILTER W/HOOKS 11/08/1990
K143208 C.R. Bard, Inc Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavain Delivery Kit 12/09/2014
K130366 C.R. BARD, INC. BARD DENALI FILTER SYSTEM- FEMORAL DELIVERY KIT AND JUGULAR DELIVERY KIT 05/15/2013
K160866 C.R. BARD, INC. Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit 04/29/2016
K101431 C.R. BARD, INC. ECLIPSE FILTER SYSTEM-FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS 06/25/2010
K093659 C.R. BARD, INC. ECLIPSE FILTER SYSTEM-FEMORAL DELIVERY KIT, ECLIPSE FILTER SYSTEM-JUGULAR/SUBCLAVIAN DELIVERY KIT MODEL RF500F MODEL RF5 01/14/2010
K082305 C.R. BARD, INC. G2 EXPRESS FILTER SYSTEM - FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS 10/31/2008
K080668 C.R. BARD, INC. G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400F) AND JUGULAR/SUBCLAVIAN (RF400J) DELIVERY KITS 07/30/2008
K102511 C.R. BARD, INC. MERIDAN FILTER SYSTEM- JUNGULAR/SUBECLAVIAN DELIVERY KIT 08/24/2011
K112497 C.R. BARD, INC. MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KIT 10/24/2011
K050558 C.R. BARD, INC. MODIFICATION TO: RECOVERY FILTER SYSTEM, MODEL RF-210F 08/29/2005
K022236 C.R. BARD, INC. RECOVERY FILTER SYSTEM, MODEL RF-048F 11/27/2002
K031328 C.R. BARD, INC. RECOVERY FILTER SYSTEM, MODEL RF-048F 07/25/2003
K073090 C.R. BARD, INC. RECOVERY G2 FILTER SYSTEM - FEMORAL DELIVERY KIT, MODEL RF-310F; JUGULAR/SUBCLAVAIN DELIVERY KIT, MODEL RF-320J 01/15/2008
K161218 COOK INCORPORATED Gianturco-Roehm BirdÆs Nest Vena Cava Filter 07/22/2016
K073528 COOK INCORPORATED VENA CAVA FILTER 02/27/2008
K032426 COOK, INC. GUNHTER TULIP VENA CAVA MREYE FILTER AND RETRIEVAL SET 10/31/2003
K072240 COOK, INC. GUNTHER TULIP VENA CAVA FILTER 11/08/2007
K043509 COOK, INC. GUNTHER TULIP VENA CAVA FILTER SET 05/05/2005
K000855 COOK, INC. GUNTHER TULIP VENA CAVA MREYE FILTER SET 10/18/2000
K023116 CORDIS CORP. CORDIS OPTEASE PERMANENT VENA CAVA FILTER, MODELS 466-F200A, 466-F200B 10/18/2002
K000062 CORDIS CORP. CORDIS TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT 07/07/2000
K010083 CORDIS CORP. TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT, MODEL 466-P306A 06/06/2001
K003964 CORDIS CORP. TRAPEASE PERMANENT VENA FILTER AND INTRODUCTION KIT, MODELS 466-P306A AND 466-P306B 01/19/2001
K091077 CORDIS CORP., A JOHNSON & JOHNSON CO. OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETER 02/04/2010
K034050 CORDIS CORPORATION CORDIS OPTEASE VENA CAVA FILTER, MODELS 466-F220A AND 466-F220B; RETRIEVABLE CATHETER, MODEL 466-C220F 03/22/2004
K140286 CORDIS, A JOHNSON & JOHNSON CO. OPTEASE VENA CAVA FILTER AND OPTEASE RETRIEVAL CATHTETER 03/07/2014
K120402 CRUX BIOMEDICAL CRUX VENA CAVA FILTER SYSTEM 07/13/2012
K122585 CRUX BIOMEDICAL CRUX VENA CAVA FILTER SYSTEM 01/17/2013
K760151 EDWARDS LABORATORIES APPLICATOR,ANGIOGRAPHY (7310MOBIN-UDDIN) 08/26/1976
K760152 EDWARDS LABORATORIES FILTER (7220&7221 MOBIN-UDDIN VENA CAVA) 07/19/1976
K771046 EDWARDS LABORATORIES VENA CAVA UMBRELLA FILTER, MODEL 7321 06/22/1977
K852097 MEDI-TECH, INC. PERCUTANEOUS GREENFIELD VENA CAVA FILTER SYSTEM 11/01/1985
K874096 MEDI-TECH, INC. TITANIUM GREENFIELD VENA CAVA FILTER CARRIER 11/04/1988
K870729 MEDI-TECH, INC. TITANIUM PERCUTANEOUS GREENFIELD VENA CAVE FILTER 04/09/1987
K940489 NITINOL MEDICAL TECHNOLOGIES, INC. SIMON NITINOL FILTER 08/09/1994
K944353 NITINOL MEDICAL TECHNOLOGIES, INC. SIMON NITINOL FILTER 04/28/1995
K894703 NITINOL MEDICAL TECHNOLOGIES, INC. SIMON NITINOL FILTER 04/20/1990
K963016 NITINOL MEDICAL TECHNOLOGIES, INC. SIMON NITINOL FILTER SYSTEM 11/18/1996
K912144 NITINOL MEDICAL TECHNOLOGIES, INC. SIMON NITINOL FILTER, MODIFICATION 10/17/1991
K970099 NITINOL MEDICAL TECHNOLOGIES, INC. SIMON NITINOL FILTER/STRAIGHT LINE SYSTEM 04/16/1997
K963014 NITINOL MEDICAL TECHNOLOGIES, INC. SIMON NITINOL FILTER/STRAIGHT LINE SYSTEM 11/18/1996
K173236 Novate Medical Ltd. Sentry IVC Filter 02/22/2018
K162875 NOVATE MEDICAL LTD. Sentry IVC filter 02/17/2017
K181202 Novate Medical Ltd. Sentry IVC Filter 06/06/2018
K081410 REX MEDICAL OPTION VENA CAVA FILTER 06/04/2009
K133243 REX MEDICAL LP OPTION ELITE VENA CAVA FILTER SYSTEM 12/17/2013
K143405 REX MEDICAL, LP Option (TM) ELITE Vena Cava Filter 100cm System 04/16/2015
K081138 RMT MEDICAL TECHNILOGIES INC. SAFEFLO VENA CAVA FILTER 05/07/2009
K881604 VENA-TECH, INC. VENA CAVA FILTER 03/10/1989
K901454 VENA-TECH, INC. VENA CAVA FILTER 05/29/1991
K150262 Volcano Corporation Crux Vena Cava Filter System, femoral; Crux Vena Cava Filter System, jugular 04/03/2015
K121057 WILLIAM COOK EUROPE APS COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS 05/04/2012
K121629 WILLIAM COOK EUROPE APS COOK CELECT PLATINUM VENA CAVA FILTER SET FOR FEMORAL APPROACH COOK CELECT PLATIUM VENA CAVA FILTER SET FOR JUGULAR APPR 07/03/2012
K171712 William Cook Europe ApS 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 08/07/2017
K061815 WILLIAM COOK EUROPE APS COOK CELECT VENA CAVA FILTER 04/20/2007
K073374 WILLIAM COOK EUROPE APS COOK CLECT VENA CAVA FILTER, GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET 03/07/2008
K112119 WILLIAM COOK EUROPE APS CUNTHER TULIP(R) VENA CAVA FILTER SET FOR FEMORAL APPROACH, COOK CELECT(R) VENA CAVA FILTER FOR FEMORAL APPROACH 03/30/2012
K172584 William Cook Europe ApS G?nther Tulip Vena Cava Filter Set for Femoral Vein Approach, G?nther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach 11/20/2017
K172557 William Cook Europe ApS 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 11/20/2017
K090140 WILLIAM COOK EUROPE APS GUNTHER TULIP VENA CAVA FILTER, COOK CELECT VENA CAVA FILTER 04/03/2009


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