BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Arrow® Multi-Lumen Central Venous Catheter with Blue FlexTip® for use only with Arrow Percutaneous Sheath Introducer

    Reg #: 1721686 · FEI: 1721686 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    27
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    1721686
    FEI Number
    1721686
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2400 Airport Rd
    City
    Santa Teresa
    State
    NM
    ZIP
    88008
    Country
    US

    Regulatory Submissions

    510(k) Number
    K862056

    Owner / Operator

    Firm Name
    Sotera Health LLC
    Operator Number
    10029425
    Address
    2015 Spring Road, Suite 650
    City
    Oak Brook
    State
    IL
    Postal Code
    60523
    Country
    US
    Correspondent
    Karen Whaley-Krumins

    Products

    Device Name Product Code
    Catheter, Percutaneous DQY

    Proprietary Names

    Arrow® Multi-Lumen Central Venous Catheter with Blue FlexTip® for use only with Arrow Percutaneous Sheath Introducer Arrow® Quad-Lumen Central Venous Catheterization Set with Blue FlexTip® Catheter Arrow® Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip® Catheter Arrow® Pediatric Multi-Lumen Central Venous Catheterization Set with Blue FlexTip® Catheter Arrow® Equipo de Cateterizacion Venosa Doble Lumen con Punta Flexible Azul Two-Lumen Central Venous Catheterization Set Arrow® Pediatric Two-Lumen Central Venous Catheterization Set with Blue FlexTip® Catheter Arrow® Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip® Catheter] Arrow® Percutaneous Sheath Introducer/Two-Lumen Central Venous Catheterization Kit Arrow® Two-Lumen Central Venous Catheter with Blue FlexTip® Arrow Select Kits Arrow® Spring-Wire Guide with Arrow Advancer¿ Arrow® HANDS-OFF® Two-Lumen Central Venous Catheter with Blue FlexTip® Arrow® Marked Spring-Wire Guide with Arrow Advancer¿ Arrow® Multi-Lumen Central Venous Catheterization Set with Blue FlexTip® Heparin-Coated Catheter Arrow® Central Venous Catheter Kit Arrow® Multi-Lumen Central Venous Catheterization Set with Blue FlexTip® Catheter Arrow® Multi-Lumen Central Venous Catheter with Blue FlexTip® Arrow® Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip® Heparin-Coated Catheter Arrow® Multi-Lumen Central Venous Catheter with Blue FlexTip® for use only with Arrow MAC¿ Two-Lumen Central Venous Acce Arrow® Two-Lumen Central Venous Catheterization Kit with Blue FlexTip® Catheter Arrow® Two-Lumen Central Venous Catheterization Set with Blue FlexTip® Catheter Arrow® Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip® Catheter For Femoral Vein Insertion Arrow® HANDS-OFF® Multi-Lumen Central Venous Catheter with Blue FlexTip® Arrow® Multi-Lumen Central Venous Catheterization with Blue FlexTip® Catheter Arrow® Two-Lumen Central Venous Catheterization Set with Blue FlexTip® ARROWg+ard Blue® Catheter CVC SET: 4-LUMEN 8.5FR X 20CM CVC KIT: 2-LUMEN 7FR X 20CM

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)