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 |
| 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 |
| 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 |
| 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 |
| K963016 | NITINOL MEDICAL TECHNOLOGIES, INC. | SIMON NITINOL FILTER SYSTEM | 11/18/1996 |
| 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 |
| 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 |
| K211875 | William Cook Europe ApS | 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 | 07/28/2021 |
| 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 | Gⁿnther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gⁿnther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach | 11/20/2017 |
| K211874 | William Cook Europe ApS | Gⁿnther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gⁿnther Tulip Vena Cava Filter Set for Jugular Vein Approach, Gⁿnther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach | 07/28/2021 |
| 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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