BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ASCENDRA BALLOON AORTIC VALVULOPLASTY CATHETER

    Reg #: 2011171 · FEI: 2011171 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    18
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics US LLC
    Registration Number
    2011171
    FEI Number
    2011171
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4900 Gifford Ave
    City
    Los Angeles
    State
    CA
    ZIP
    90058
    Country
    US

    Regulatory Submissions

    PMA Number
    P130009

    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
    Aortic Valve, Prosthesis, Percutaneously Delivered NPT

    Proprietary Names

    ASCENDRA BALLOON AORTIC VALVULOPLASTY CATHETER ASCENDRA+ DELIVERY SYSTEM WITH CRIMP STOPPER ASCENDRA+ INTRODUCER SHEATH SET CRIMPER NOVAFLEX+ DELIVERY SYSTEM WITH CRIMP STOPPER AND QUALCRIMP CRIMPING ACCESSORY (LAMINATED MODEL OR CLOTH MODEL 9300QC) EDWARDS SAPIEN XT™ TRANSCATHETER HEART VALVE AND ACCESSORIES EDWARDS TRANSFEMORAL BALLOON CATHETER EDWARDS EXPANDABLE INTRODUCER SHEATH SET Edwards Crimper Ascendra + Introducer Sheath Set Edwards Dilator Kit Ascendra + Delivery System Qualcrimp crimping accessory Ascendra + System NovaFlex + Delivery System Edwards Expandable Introducer Sheath Set Edwards SAPIEN XT Transcatheter Heart Valve NovaFlex + System Crimp Stopper

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)