Panels › Cardiovascular › Product code DTK · Class 2
Filter, Intravascular, Cardiovascular
Regulation 870.3375
0510(k)s in 12 months (83 all time)
1recalls in 12 months (22 all time)
22recalls that name a 510(k)
Top companies in DTK
| Company | 510(k)s | Recalls |
|---|---|---|
| C.R. Bard, Inc. | 13 | 0 |
| William Cook Europe Aps | 12 | 0 |
| Boston Scientific Corp | 6 | 2 |
| Cook Medical Incorporated | 0 | 8 |
| Bard Peripheral Vascular | 2 | 5 |
| Cordis Corp. | 5 | 2 |
| Nitinol Medical Technologies, Inc. | 7 | 0 |
| Cook Incorporated | 6 | 0 |
| Aln Implants Chirurgicaux | 3 | 0 |
| Argon Medical Devices, Inc. | 1 | 2 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 10, 2024 | K242612 | Option ELITE Vena Cava Filter System (352506070E 352506100E) Argon Medical Devices, Inc. | DTK |
| Jul 31, 2024 | K240578 | VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System B.Braun Medical, Inc. | DTK |
| Jun 26, 2024 | K241507 | ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK) Aln S.A.R.L., FR | DTK |
| Feb 29, 2024 | K240257 | Denali Vena Cava Filter System Femoral and Jugular/Subclavian Delivery Kit Bd | DTK |
| Jan 18, 2024 | K233680 | Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT); Celect Platinum Vena Cava Fi William Cook Europe Aps, DK | DTK |
| Jul 28, 2021 | K211875 | Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filte Set for Jugula William Cook Europe Aps, DK | DTK |
| Jul 28, 2021 | K211874 | Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approa William Cook Europe Aps, DK | DTK |
| Jun 6, 2018 | K181202 | Sentry IVC Filter Novate Medical , Ltd., IE | DTK |
| Feb 22, 2018 | K173236 | Sentry IVC Filter Novate Medical , Ltd., IE | DTK |
| Nov 20, 2017 | K172584 | Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular William Cook Europe Aps, DK | DTK |
| Nov 20, 2017 | K172557 | Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular Vein Approa William Cook Europe Aps, DK | DTK |
| Sep 8, 2017 | K163699 | ALN Optional Vena Cava Filter - Femoral Approach, ALN Optional Vena Cava Filter - Jugular Approach, ALN Optional Vena Ca Aln Implants Chirurgicaux, FR | DTK |
| Aug 7, 2017 | K171712 | Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Jugul William Cook Europe Aps, DK | DTK |
| Feb 17, 2017 | K162875 | Sentry IVC filter Novate Medical , Ltd., IE | DTK |
| Jul 22, 2016 | K161218 | Gianturco-Roehm Birds Nest Vena Cava Filter Cook Incorporated | DTK |
| Apr 29, 2016 | K160866 | Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit C.R. Bard, Inc. | DTK |
| Feb 26, 2016 | K152765 | VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM B. Braun Interventional Systems, Inc. | DTK |
| Apr 16, 2015 | K143405 | Option (TM) ELITE Vena Cava Filter 100cm System Rex Medical, L.P. | DTK |
| Apr 3, 2015 | K150262 | Crux Vena Cava Filter System, femoral; Crux Vena Cava Filter System, jugular Volcano Corporation | DTK |
| Dec 9, 2014 | K143208 | Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavain Delivery Kit C.R. Bard, Inc. | DTK |
| Mar 7, 2014 | K140286 | OPTEASE VENA CAVA FILTER AND OPTEASE RETRIEVAL CATHTETER Cordis, A Johnson & Johnson Co. | DTK |
| Dec 17, 2013 | K133243 | OPTION ELITE VENA CAVA FILTER SYSTEM Rex Medical, L.P. | DTK |
| May 15, 2013 | K130366 | BARD DENALI FILTER SYSTEM- FEMORAL DELIVERY KIT AND JUGULAR DELIVERY KIT C.R. Bard, Inc. | DTK |
| Jan 17, 2013 | K122585 | CRUX VENA CAVA FILTER SYSTEM Crux Biomedical | DTK |
| Nov 9, 2012 | K113124 | ALN OPTIONAL VANA CAVA FILTER Aln Implants Chirurgicaux, FR | DTK |
| Jul 13, 2012 | K120402 | CRUX VENA CAVA FILTER SYSTEM Crux Biomedical | DTK |
| Jul 3, 2012 | 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 | DTK |
| May 4, 2012 | K121057 | COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS William Cook Europe Aps | DTK |
| Mar 30, 2012 | K112119 | CUNTHER TULIP(R) VENA CAVA FILTER SET FOR FEMORAL APPROACH, COOK CELECT(R) VENA CAVA FILTER FOR FEMORAL APPROACH William Cook Europe Aps | DTK |
| Oct 24, 2011 | K112497 | MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KIT C.R. Bard, Inc. | DTK |
| Aug 24, 2011 | K102511 | MERIDAN FILTER SYSTEM- JUNGULAR/SUBECLAVIAN DELIVERY KIT C.R. Bard, Inc. | DTK |
| Jun 25, 2010 | K101431 | ECLIPSE FILTER SYSTEM-FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS C.R. Bard, Inc. | DTK |
| Feb 4, 2010 | K091077 | OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETER Cordis Corp., A Johnson & Johnson Co. | DTK |
| Jan 14, 2010 | K093659 | ECLIPSE FILTER SYSTEM-FEMORAL DELIVERY KIT, ECLIPSE FILTER SYSTEM-JUGULAR/SUBCLAVIAN DELIVERY KIT MODEL RF500F MODEL RF5 C.R. Bard, Inc. | DTK |
| Jun 4, 2009 | K081410 | OPTION VENA CAVA FILTER Rex Medical | DTK |
| May 7, 2009 | K081138 | SAFEFLO VENA CAVA FILTER Rmt Medical Technilogies, Inc. | DTK |
| Apr 3, 2009 | K090140 | GUNTHER TULIP VENA CAVA FILTER, COOK CELECT VENA CAVA FILTER William Cook Europe Aps | DTK |
| Oct 31, 2008 | K082305 | G2 EXPRESS FILTER SYSTEM - FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS C.R. Bard, Inc. | DTK |
| Jul 30, 2008 | K080668 | G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400F) AND JUGULAR/SUBCLAVIAN (RF400J) DELIVERY KITS C.R. Bard, Inc. | DTK |
| Mar 7, 2008 | K073374 | COOK CLECT VENA CAVA FILTER, GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET William Cook Europe Aps | DTK |
| Feb 27, 2008 | K073528 | VENA CAVA FILTER Cook Incorporated | DTK |
| Jan 30, 2008 | K070514 | ALN OPTIONAL VENA CAVA FILTER-FEMORAL APPROACH, JUGULAR APPROACH, BRACHIAL APPROACH, EXTRACTION KIT, PRECURVED EXTRACTIO Aln Implants Chirurgicaux | DTK |
| Jan 15, 2008 | K073090 | RECOVERY G2 FILTER SYSTEM - FEMORAL DELIVERY KIT, MODEL RF-310F; JUGULAR/SUBCLAVAIN DELIVERY KIT, MODEL RF-320J C.R. Bard, Inc. | DTK |
| Nov 8, 2007 | K072240 | GUNTHER TULIP VENA CAVA FILTER Cook, Inc. | DTK |
| Apr 20, 2007 | K061815 | COOK CELECT VENA CAVA FILTER William Cook Europe Aps | DTK |
| Jan 12, 2007 | K063217 | VENATECH LP BRACHIAL INTRODUCER SYSTEM (ANTECUBITAL) B.Braun Medical, Inc. | DTK |
| Oct 26, 2006 | K062887 | MODIFICATION TO G2 FILTER SYSTEM-FEMORAL DELIVERY KIT, MODEL RF-310F Bard Peripheral Vascular | DTK |
| Nov 25, 2005 | K052578 | BARD G2 FILTER SYSTEM - JUGULAR/SUBCLAVIAN DELIVERY KIT, MODEL RF-320J Bard Peripheral Vascular, Inc. | DTK |
| Aug 29, 2005 | K050558 | MODIFICATION TO: RECOVERY FILTER SYSTEM, MODEL RF-210F C.R. Bard, Inc. | DTK |
| May 5, 2005 | K043509 | GUNTHER TULIP VENA CAVA FILTER SET Cook, Inc. | DTK |
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