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)
- 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)
- 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)
- 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)
Show All 84 Submissions
- 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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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 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 Filter
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K233680
- 510(k) Type
- Traditional
- Applicant
- William Cook Europe ApS
- Country
- Denmark
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/18/2024
- Days to Decision
- 63 days
- Submission Type
- Summary