BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EDWARDS LIFESCIENCES LLC

    Reg #: 2015691 · FEI: 2015691 · Expires 2026
    View on FDA
    Products
    25
    Proprietary Names
    114
    Establishment Types
    2
    Classifications
    25

    Registration Details

    Registration Name
    EDWARDS LIFESCIENCES LLC
    Registration Number
    2015691
    FEI Number
    2015691
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    ONE EDWARDS WAY
    City
    IRVINE
    State
    CA
    ZIP
    92614
    Country
    US

    Regulatory Submissions

    510(k) Number
    K244046
    PMA Number
    P860057

    Owner / Operator

    Firm Name
    Edwards Lifesciences LLC
    Operator Number
    9040666
    Address
    One Edwards Way
    City
    Irvine
    State
    CA
    Postal Code
    92614
    Country
    US
    Correspondent
    Denny Kouri

    Products

    Device Name Product Code
    Introducer, Catheter DYB
    Instruments, Surgical, Cardiovascular DWS
    Catheter, Continuous Flush KRA
    Catheter, Embolectomy DXE
    Replacement Heart-Valve DYE
    Prosthesis, Mitral Valve, Percutaneously Delivered NPU
    Tray, Surgical, Instrument FSM
    Cardiovascular Delivery Catheter System Positioning And Stabilization Device QWA
    Clamp, Vascular DXC
    Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF
    Ring, Annuloplasty KRH
    Percutaneously Delivered Prostheses And Tricuspid Valves NPW
    Balloon Aortic Valvuloplasty OZT
    Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene DXZ
    Heart-Valve, Non-Allograft Tissue LWR
    Mitral Valve Repair Devices NKM
    Stabilizer, Heart MWS
    Cannula, Catheter DQR
    Aortic Valve, Prosthesis, Percutaneously Delivered NPT
    Pulmonary Valve Prosthesis Percutaneously Delivered NPV
    Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter OMZ
    Sizer, Heart-Valve, Prosthesis DTI
    Holder, Heart-Valve, Prosthesis DTJ
    Dilator, Vessel, For Percutaneous Catheterization DRE
    Catheter, Septostomy DXF

    Proprietary Names

    Edwards eSheath Optima introducer set Valve Placement Pack Minimally Invasive Suturing Instrument Knot Tying Instrument Valve Probe, Valve Seater, Knot Pusher Knot Pusher EMBOL-X AORTIC SIZERS Fogarty Thru-Lumen Embolectomy Catheter Carpentier-Edwards Perimount Bioprosthesis SAPIEN M3 TRANSCATHETER MITRAL VALVE REPLACEMENT SYSTEM TRAY, SURGICAL, INSTRUMENT Thruport Introducer Sheath Edwards eSheath+ introducer set PASCAL System - Table PASCAL System - Stabilizer Rail System Edwards Reusable Accessories - Reusable Platform Edwards Reusable Accessories - Reusable Cradle Edwards EVOQUE Accessories Edwards Reusable Rail Extension Edwards Reusable Accessories - Reusable Plate Edwards Stabilizer Rail System Edwards Stabilizer Set Edwards Rail Tray Edwards Reusable Rail Edwards EVOQUE Stabilizer IntraClude Intra-Aortic Occlusion Device Axillary Access Arterial Cannulae Physio Flex Annuloplasty Ring PHYSIO FLEX Annuloplasty Ring INTRODUCER SHEATH KIT, 9 FR Intraclude Edwards EVOQUE Loading System and Trimmer Edwards EVOQUE EVOQUE tricuspid delivery system, dilator kit, and loading system Edwards EVOQUE valve EVOQUE CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING Ascendra Balloon Aortic Valvuloplasty Catheter Thruport Proplege Peripheral Retrograde Cardioplegia Device Edwards Pericardial Patch CARPENTIER-McCARTHY-ADAMS IMR ETLOGIX MITRAL ANNULOPLASTY RING EDWARDS INTUITY Elite Valve System RetroFlex3 Introducer Sheath Set PASCAL Precision Transcatheter Valve Repair System JANKE-BARRON HEART SUPPORT Aortic Perfusion Cannulae Porous Vent plugs Femoral Venous Cannula Fem-Flex II Femoral Arterial Cannula FemTrak Femoral Venous Cannula Fem-Flex II Femoral Venous Cannula OptiSite Arterial Cannula Edwards Pericadial Patch Pediatric Peripheral access arterial cannulae Retrograde Cardioplegia Catheters Qualcrimp crimping accessory Edwards Crimper Edwards Expandable Introducer Sheath Set Edwards SAPIEN XT Transcatheter Heart Valve Ascendra+ System NovaFlex + Delivery System Crimp Stopper NovaFlex+ System Ascendra+ Delivery System Ascendra + Introducer Sheath Set Edwards Dilator Kit CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING Cosgrove-Edwards Annuloplasty Ring Edwards Balloon Catheter-9350BC23 Edwards Balloon Catheter-9350BC20 Edwards Balloon Catheter-9350BC16 Edwards Balloon Catheter-9350BC25 Edwards Balloon Catheter EDWARDS MC3 TRICUSPID ANNULOPLASTY RING Arterial perfusion cannulae Edwards SAPIEN 3 Transcatheter Heart Valve Edwards Commander Delivery System Edwards Certitude Introducer Sheath Edwards Certitude Delivery System Edwards SAPIEN 3 Ultra Transcatheter Heart Valve Edwards Certitude Introducer Sheath Set Edwards eSheath Introducer Set- 914ES eSheath- 914ES Edwards eSheath Introducer Set- 916ES eSheath- 916ES Edwards COMMANDER Delivery System Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve Vascular Tourniquet Edwards SAPIEN 3 Transcather Pulmonary Valve System with Alterra Adaptive Prestent Edwards SAPIEN 3 Pulmonic Delivery System Edwards SAPIEN 3 Transcatheter Pulmonic Valve Delivery System HEART VALVE SIZER Carpentier-Edwards Physio Annuloplasty Ring QuickDraw Venous Cannula Heart-Valve Holder Miller Balloon Atrioseptostomy Fogarty Dilation Atrioseptostomy Venous Cannulae Femoral Access Arterial INSPIRIS RESILIA Aortic Valve Edwards Pericardial Aortic Bioprosthesis KONECT RESILIA Aortic Valved Conduit MITRIS RESILIA Mitral Valve TRIFORMIS RESILIA Tricuspid Valve Thruport Endoreturn Arterial Cannulae Edwards eSheath Introducer Set Edwards MC3 Tricuspid Annuloplasty Ring Single Stage Venous Drainage Cannula Vent Catheters Classic Annuloplasty Ring Thruport Endovent Pulmonary Catheters Femoral Access Venous Cannula INTRODUCER SHEATH KIT,11 FR Carpentier-Edwards Physio Ring

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility