Anesthesiology
Review Panel
- CardiovascularReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- DSTClip, Vena-Cava2Product Code
- DSWBag, Polymeric Mesh, Pacemaker1Product Code
- DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter2Product Code
- DSZPacemaker Battery3Product Code
- DTATester, Pacemaker Electrode Function2Product Code
- DTBPermanent Pacemaker Electrode3Product Code
- DTCAnalyzer, Pacemaker Generator Function2Product Code
- DTDPacemaker Lead Adaptor2Product Code
- DTEPulse-Generator, Pacemaker, External2Product Code
- DTFTools, Pacemaker Service1Product Code
- DTGMagnet, Test, Pacemaker1Product Code
- DTISizer, Heart-Valve, Prosthesis1Product Code
- DTJHolder, Heart-Valve, Prosthesis1Product Code
- DTKFilter, Intravascular, Cardiovascular2Product Code
- K242612Option ELITE Vena Cava Filter System (352506070E 352506100E)2Cleared 510(K)
- K240578VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System2Cleared 510(K)
- K241507ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)2Cleared 510(K)
- K240257Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit2Cleared 510(K)
- K233680Celect 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 Filter2Cleared 510(K)
- K211874Günther 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 Approach2Cleared 510(K)
- K211875Cook 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 Approach2Cleared 510(K)
- K181202Sentry IVC Filter2Cleared 510(K)
- K173236Sentry IVC Filter2Cleared 510(K)
- K172584Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach2Cleared 510(K)
- K172557Gunther 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 Approach2Cleared 510(K)
- K163699ALN 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 Hook2Cleared 510(K)
- K171712Cook 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 Approach2Cleared 510(K)
- K162875Sentry IVC filter2Cleared 510(K)
- K161218Gianturco-Roehm Bird’s Nest Vena Cava Filter2Cleared 510(K)
- K160866Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit2Cleared 510(K)
- K152765VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM2Cleared 510(K)
- K143405Option (TM) ELITE Vena Cava Filter 100cm System2Cleared 510(K)
- K150262Crux Vena Cava Filter System, femoral; Crux Vena Cava Filter System, jugular2Cleared 510(K)
- K143208Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavain Delivery Kit2Cleared 510(K)
- K140286OPTEASE VENA CAVA FILTER AND OPTEASE RETRIEVAL CATHTETER2Cleared 510(K)
- K133243OPTION ELITE VENA CAVA FILTER SYSTEM2Cleared 510(K)
- K130366BARD DENALI FILTER SYSTEM- FEMORAL DELIVERY KIT AND JUGULAR DELIVERY KIT2Cleared 510(K)
- K122585CRUX VENA CAVA FILTER SYSTEM2Cleared 510(K)
- K113124ALN OPTIONAL VANA CAVA FILTER2Cleared 510(K)
- K120402CRUX VENA CAVA FILTER SYSTEM2Cleared 510(K)
- K121629COOK CELECT PLATINUM VENA CAVA FILTER SET FOR FEMORAL APPROACH COOK CELECT PLATIUM VENA CAVA FILTER SET FOR JUGULAR APPR2Cleared 510(K)
- K121057COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS2Cleared 510(K)
- K112119CUNTHER TULIP(R) VENA CAVA FILTER SET FOR FEMORAL APPROACH, COOK CELECT(R) VENA CAVA FILTER FOR FEMORAL APPROACH2Cleared 510(K)
- K112497MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KIT2Cleared 510(K)
- K102511MERIDAN FILTER SYSTEM- JUNGULAR/SUBECLAVIAN DELIVERY KIT2Cleared 510(K)
- K101431ECLIPSE FILTER SYSTEM-FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS2Cleared 510(K)
- K091077OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETER2Cleared 510(K)
- K093659ECLIPSE FILTER SYSTEM-FEMORAL DELIVERY KIT, ECLIPSE FILTER SYSTEM-JUGULAR/SUBCLAVIAN DELIVERY KIT MODEL RF500F MODEL RF52Cleared 510(K)
- K081410OPTION VENA CAVA FILTER2Cleared 510(K)
- K081138SAFEFLO VENA CAVA FILTER2Cleared 510(K)
- K090140GUNTHER TULIP VENA CAVA FILTER, COOK CELECT VENA CAVA FILTER2Cleared 510(K)
- K082305G2 EXPRESS FILTER SYSTEM - FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS2Cleared 510(K)
- K080668G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400F) AND JUGULAR/SUBCLAVIAN (RF400J) DELIVERY KITS2Cleared 510(K)
- K073374COOK CLECT VENA CAVA FILTER, GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET2Cleared 510(K)
- K073528VENA CAVA FILTER2Cleared 510(K)
- K070514ALN OPTIONAL VENA CAVA FILTER-FEMORAL APPROACH, JUGULAR APPROACH, BRACHIAL APPROACH, EXTRACTION KIT, PRECURVED EXTRACTIO2Cleared 510(K)
- K073090RECOVERY G2 FILTER SYSTEM - FEMORAL DELIVERY KIT, MODEL RF-310F; JUGULAR/SUBCLAVAIN DELIVERY KIT, MODEL RF-320J2Cleared 510(K)
- K072240GUNTHER TULIP VENA CAVA FILTER2Cleared 510(K)
- K061815COOK CELECT VENA CAVA FILTER2Cleared 510(K)
- K063217VENATECH LP BRACHIAL INTRODUCER SYSTEM (ANTECUBITAL)2Cleared 510(K)
- K062887MODIFICATION TO G2 FILTER SYSTEM-FEMORAL DELIVERY KIT, MODEL RF-310F2Cleared 510(K)
- P850049BIRD'S NEST VENA CAVA FILTER2PMA Approval
- K052578BARD G2 FILTER SYSTEM - JUGULAR/SUBCLAVIAN DELIVERY KIT, MODEL RF-320J2Cleared 510(K)
- K050558MODIFICATION TO: RECOVERY FILTER SYSTEM, MODEL RF-210F2Cleared 510(K)
- K043509GUNTHER TULIP VENA CAVA FILTER SET2Cleared 510(K)
- K034050CORDIS OPTEASE VENA CAVA FILTER, MODELS 466-F220A AND 466-F220B; RETRIEVABLE CATHETER, MODEL 466-C220F2Cleared 510(K)
- K032426GUNHTER TULIP VENA CAVA MREYE FILTER AND RETRIEVAL SET2Cleared 510(K)
- K031328RECOVERY FILTER SYSTEM, MODEL RF-048F2Cleared 510(K)
- K022236RECOVERY FILTER SYSTEM, MODEL RF-048F2Cleared 510(K)
- K023116CORDIS OPTEASE PERMANENT VENA CAVA FILTER, MODELS 466-F200A, 466-F200B2Cleared 510(K)
- P850049GIANTURCO-ROEHM BIRD'S NEST(TM) VENA CAVA FILTER2PMA Approval
- K010083TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT, MODEL 466-P306A2Cleared 510(K)
- K010485VENA TECH VENA CAVA FILTER; VENA TECH 30D VENA CAVA FILTER; VENA TECH LP CAVE FILTER2Cleared 510(K)
- K003964TRAPEASE PERMANENT VENA FILTER AND INTRODUCTION KIT, MODELS 466-P306A AND 466-P306B2Cleared 510(K)
- K000855GUNTHER TULIP VENA CAVA MREYE FILTER SET2Cleared 510(K)
- K000062CORDIS TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT2Cleared 510(K)
- P850049GIANTURCO-ROEHM BIRD'S NEST VENA CAVA FILTER2PMA Approval
- P850049GIANTURCO-ROEHM BIRD'S NEST VENA CAVA FILTER2PMA Approval
- K970099SIMON NITINOL FILTER/STRAIGHT LINE SYSTEM2Cleared 510(K)
- K964284STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F INTRODUCER SYSTEM2Cleared 510(K)
- K963016SIMON NITINOL FILTER SYSTEM2Cleared 510(K)
- K963014SIMON NITINOL FILTER/STRAIGHT LINE SYSTEM2Cleared 510(K)
- P850049COOK BIRD'S NEST VENA CAVA FILTER2PMA Approval
- K955396STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F FLEXCARRIER INTRODUCTER SYSTEM2Cleared 510(K)
- K951508STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 24F INTRODUCER SYSTEM2Cleared 510(K)
- K912035STAINLESS STEEL GREEN VENA CAVA FILT W/12F INTR SY2Cleared 510(K)
- K944353SIMON NITINOL FILTER2Cleared 510(K)
- P850049COOK BIRD'S NEST VENA CAVA FILTER2PMA Approval
- K940489SIMON NITINOL FILTER2Cleared 510(K)
- P850049COOK BIRD'S NEST VENA CAVA FILTER2PMA Approval
- K932921PERCUTANEOUS INTRODUCER FOR VENA CAVA FILTER SYST2Cleared 510(K)
- P850049COOK BIRD'S NEST VENA CAVA FILTER2PMA Approval
- K925679VENA CAVA FILTER SYSTEMS, MODIFICATION2Cleared 510(K)
- K912144SIMON NITINOL FILTER, MODIFICATION2Cleared 510(K)
- K901454VENA CAVA FILTER2Cleared 510(K)
- P850049COOK BIRD'S NEST VENA CAVA FILTER2PMA Approval
- K901659TITANIUM GREENFIELD(R) VENA CAVA FILTER W/HOOKS2Cleared 510(K)
- K901235GREENFIELD VENA CAVA FILTER W/19.5 FR INTRODUCER2Cleared 510(K)
- K894703SIMON NITINOL FILTER2Cleared 510(K)
- P850049COOK BIRD'S NEST VENA CAVA FILTER2PMA Approval
- K881604VENA CAVA FILTER2Cleared 510(K)
- K874096TITANIUM GREENFIELD VENA CAVA FILTER CARRIER2Cleared 510(K)
- K870729TITANIUM PERCUTANEOUS GREENFIELD VENA CAVE FILTER2Cleared 510(K)
- K852097PERCUTANEOUS GREENFIELD VENA CAVA FILTER SYSTEM2Cleared 510(K)
- K771046VENA CAVA UMBRELLA FILTER, MODEL 73212Cleared 510(K)
- K760151APPLICATOR,ANGIOGRAPHY (7310MOBIN-UDDIN)2Cleared 510(K)
- K760152FILTER (7220&7221 MOBIN-UDDIN VENA CAVA)2Cleared 510(K)
- DSPSystem, Balloon, Intra-Aortic And Control2Product Code
- DSRStimulator, Carotid Sinus Nerve3Product Code
- DSSClip, Vascular2Product Code
- DXYImplantable Pacemaker Pulse-Generator3Product Code
- DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene2Product Code
- DYEReplacement Heart-Valve3Product Code
- DYFProsthesis, Vascular Graft, Of Less Then 6mm Diameter2Product Code
- KFJMaterials, Repair Or Replacement, Pacemaker3Product Code
- KRDDevice, Vascular, For Promoting Embolization2Product Code
- KREAnalyzer, Pacemaker Generator Function, Indirect2Product Code
- KRFCharger, Pacemaker1Product Code
- KRGProgrammer, Pacemaker3Product Code
- KRHRing, Annuloplasty2Product Code
- LDFElectrode, Pacemaker, Temporary2Product Code
- MABMarker, Cardiopulmonary Bypass (Vein Marker)2Product Code
- MALGraft, Vascular, Synthetic/Biologic Composite2Product Code
- MFXVessel Guard Or Cover, To Facilitate Revision Surgeries2Product Code
- MOPRotator, Prosthetic Heart Valve1Product Code
- MZYGraft, Vascular, Stainless Steel Tunneler2Product Code
- NHWElectrode, Pacing And Cardioversion, Temporary, Epicardial2Product Code
- NKOSystem, Balloon, Intra-Aortic And Control, Reprocessed3Product Code
- OKRVentricular Bypass (Assist) Device3Product Code
- OMHPericardial Patch To Facilitate Revision Surgeries2Product Code
- OMRVessel Guard Or Cover2Product Code
- OTDEndovascular Suturing System2Product Code
- OVJPulse Generator, External Pacemaker, Dual Chamber2Product Code
- PALPulmonic Replacement Heart ValveFProduct Code
- PCKPediatric Ventricular Assist DeviceFProduct Code
- PNJLeadless Pacemaker3Product Code
- PNSShort-Term Intravascular Filter Catheter2Product Code
- PSQIntracardiac Patch Or Pledget, Biologically Derived2Product Code
- PSTAortic Annuloplasty Ring2Product Code
- QABPacing System Analyzer2Product Code
- Subpart E—Cardiovascular Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavain Delivery Kit
- Page Type
- Cleared 510(K)
- 510(k) Number
- K143208
- 510(k) Type
- Special
- Applicant
- C.R. Bard, Inc
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/9/2014
- Days to Decision
- 29 days
- Submission Type
- Summary