BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Edwards Balloon Catheter-9350BC20

    Reg #: 2011171 · FEI: 2011171 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    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

    510(k) Number
    K153069

    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
    Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter OMZ

    Proprietary Names

    Edwards Balloon Catheter-9350BC20 Edwards Balloon Catheter-9350BC16 Edwards Balloon Catheter-9350BC25 Edwards Balloon Catheter-9350BC23

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)