BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Edwards Lifesciences LLC

    Reg #: 3008500478 · FEI: 1713910 · Expires 2026
    View on FDA
    Products
    28
    Proprietary Names
    122
    Establishment Types
    1
    Classifications
    28

    Registration Details

    Registration Name
    Edwards Lifesciences LLC
    Registration Number
    3008500478
    FEI Number
    1713910
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    12050 Lone Peak Parkway
    City
    Draper
    State
    UT
    ZIP
    84020
    Country
    US

    Regulatory Submissions

    510(k) Number
    K960098
    PMA Number
    P200015

    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
    Cannula, Catheter DQR
    Retractor GAD
    Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF
    Introducer, Catheter DYB
    Pulmonary Valve Prosthesis Percutaneously Delivered NPV
    Clamp, Vascular DXC
    Catheter, Intravascular, Diagnostic DQO
    Filter, Blood, Cardiopulmonary Bypass, Arterial Line DTM
    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
    Handle, Scalpel GDZ
    Instruments, Surgical, Cardiovascular DWS
    Suction Control, Intracardiac, Cardiopulmonary Bypass DWD
    Balloon Aortic Valvuloplasty OZT
    Prosthesis, Mitral Valve, Percutaneously Delivered NPU
    Mitral Valve Repair Devices NKM
    Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter OMZ
    Cardiovascular Delivery Catheter System Positioning And Stabilization Device QWA
    Percutaneously Delivered Prostheses And Tricuspid Valves NPW
    Snare, Surgical GAE
    Ring, Annuloplasty KRH
    Lavage, Jet FQH
    Holder, Heart-Valve, Prosthesis DTJ
    Sizer, Heart-Valve, Prosthesis DTI
    Catheter Introducer Kit OFD
    Heart-Valve, Non-Allograft Tissue LWR
    Dilator, Vessel, For Percutaneous Catheterization DRE
    Aortic Valve, Prosthesis, Percutaneously Delivered NPT
    Hook, Surgical, General & Plastic Surgery GDG

    Proprietary Names

    Internal Mammary Artery Cannulae Manual surgical instr., general use QuickDraw Venous Cannula Suction Wands and Sumps RetroFlex3 Introducer Sheath Set Edwards SAPIEN 3 Transcatheter Heart Valve Edwards Crimper Edwards Commander Delivery System 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 IntraClude Intra-Aortic Occlusion Device Tapered carotid bypass shunts Thruport Endodirect Arterial Cannula Left Atrial Pressure Monitoring Catheter OptiSite Arterial Cannula Vent Catheters EMBOL-X ARTERIAL FILTER Cardioplegia delivery monitoring and infusion sets Thruport Intraclude Intra-Aortic Occlusion Device Thruport Introducer Sheath Thruport Endoclamp Aortic Catheters Intraclude Vascular Tourniquet Arterial perfusion cannulae Axillary Access Arterial Cannulae Manual surgical instr. general use Valve Placement Pack Minimally Invasive Suturing Instrument Knot Tying Instrument Valve Probe, Valve Seater, Knot Pusher Knot Pusher EMBOL-X AORTIC SIZERS Anastaflo Intravascular Shunts Duraflo-treated femoral cannulae Antegrade Cardioplegia Cannula INTRODUCER SHEATH KIT, 9 FR Duraflo-Treated Suction Wands INTRODUCER SHEATH KIT,11 FR Edwards Balloon Catheter Single Stage Venous Drainage Cannula Cardioplegia Kits SAPIEN M3 TRANSCATHETER MITRAL VALVE REPLACEMENT SYSTEM Venous Cannulae Femoral Access Arterial PASCAL Precision Transcatheter Valve Repair System Edwards Balloon Catheter-9350BC23 Edwards Balloon Catheter-9350BC20 Edwards Balloon Catheter-9350BC16 Edwards Balloon Catheter-9350BC25 Port Access EV cardiopulmonary bypass system Femoral Access Arterial Cannula Femoral Venous Cannula Fem-Flex II Femoral Arterial Cannula FemTrak Femoral Venous Cannula Fem-Flex II Femoral Venous Cannula 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 Porous Vent plugs Vasoplegia cannulae Embol-X arterial cannulae Retrograde Cardioplegia Catheters Edwards eSheath+ introducer set Thruport Endovent Pulmonary Catheters Edwards EVOQUE Loading System and Trimmer Edwards EVOQUE EVOQUE tricuspid delivery system, dilator kit, and loading system Edwards EVOQUE valve EVOQUE EXIS EMBOL-X Introducer Sheath Aortic Perfusion Cannulae Ascendra Balloon Aortic Valvuloplasty Catheter Physio Flex Annuloplasty Ring PHYSIO FLEX Annuloplasty Ring Pediatric Peripheral access arterial cannulae Thruport Proplege Peripheral Retrograde Cardioplegia Device VisuFlo Blower Thruport Endoplege Coronary Sinus Catheter Heart-Valve Holder HEART VALVE SIZER FAPCath Femoral arterial pressure monitoring catheter PIKA Percutaneous Insertion Kit Aortic Pressure monitoring extension lines Thruport Endoreturn Arterial Cannulae Cardioplegia Delivery Sets EDWARDS INTUITY Elite Valve System Vascushunt carotid shunts Edwards Dilator Kit EDWARDS MC3 TRICUSPID ANNULOPLASTY RING Qualcrimp crimping accessory 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 eSheath Introducer Set Carotid shunts 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 Femoral Access Venous Cannula

    Establishment Types

    Manufacture Medical Device