BEUDAMED
    FDA Registration Active 🇺🇸 United States

    LivaNova USA, INC.

    Reg #: 1718850 · FEI: 1718850 · Expires 2026
    View on FDA
    Products
    18
    Proprietary Names
    64
    Establishment Types
    6
    Classifications
    18

    Registration Details

    Registration Name
    LivaNova USA, INC.
    Registration Number
    1718850
    FEI Number
    1718850
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    14401 WEST 65TH WAY
    City
    ARVADA
    State
    CO
    ZIP
    80004
    Country
    US

    Regulatory Submissions

    510(k) Number
    K792134

    Owner / Operator

    Firm Name
    LivaNova
    Operator Number
    9003795
    Address
    14401 W 65th Way
    City
    Arvada
    State
    CO
    Postal Code
    80004
    Country
    US

    Products

    Device Name Product Code
    Lavage, Jet FQH
    Catheter, Ventricular, General & Plastic Surgery GBS
    Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF
    Dilator, Vessel, Surgical DWP
    Tubing, Pump, Cardiopulmonary Bypass DWE
    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
    Continuous Measurement Thermometer FLL
    Dual Lumen Ecmo Cannula PZS
    Dilator, Vessel, For Percutaneous Catheterization DRE
    Snare, Surgical GAE
    Accessory Equipment, Cardiopulmonary Bypass KRI
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Laparoscope, General & Plastic Surgery GCJ
    Sucker, Cardiotomy Return, Cardiopulmonary Bypass DTS
    Apparatus, Autotransfusion CAC
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Reservoir, Blood, Cardiopulmonary Bypass DTN
    Cpb Check Valve, Retrograde Flow, In-Line MJJ

    Proprietary Names

    Mister Thoracic Catheter EasyFlow and EasyFlow Duo Boncheck Vein Distention System BSVD Transseptal Cannule set EF 72 SMARxT Tubing and Connectors Perfusion Pack Cardioplegia Pack Perfusion Tubing Tubing Perfusion Packs Temperature Probe Venous Return Cannula Protek Duo 31 Fr RD Protek Duo 31 Fr Protek Duo 29 Fr Vent Catheter ProtekDilate Vascular Access Kit Femoral Arterial Cannule Set 17 Fr Vasco Loop Clamps Oxygen Filter Brackets Holders Fittings Femoral Arterial Cannule Set 15 Fr Vein Irrigation Cannula Protek Duo 31 Fr Mini VascuLoop Cardiac Insulation Pads Suction Wand Suction Sump EC Series Connectors Vascular Dilator Kit BRAT2 System and Accessories Dual Stage Venous Cannula Protek Solo 24 FR Aortic Arch Cannula Dual Stage Venous Return Cannula Tri Stage Venous Return Cannula SCCA Cardioplegia Adapter Perfusion Adapter Pressure Monitoring Line Femoral Arterial Cannule Set 14 Fr Cannulation Tourniquet Coronary Artery Perfusion Cannula Protek Venous Dilator set Endoscopic Monopolar Instrument Orthofuser Wound Drainage/Autotransfusion System Cardoplegia Pack Cardioplegia System Connectors SMARxT RAP Cannula Vacuum Relief Check Valve Retrograde Cardioplega Cannula Transseptal Cannule set EF 62 Retrograde Cardioplegia Cannula Aortic Root Cannula Air Aspirator Vessel Cannula VascuClear Precision Bipolar

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Sterilize Medical Device for Another Party (Contract Sterilizer) Develop Specifications But Do Not Manufacture At This Facility Manufacture Device in the United States for Export Only Repack or Relabel Medical Device