BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Medline ReNewal Reprocessed Siemens ACUSON AcuNav Ultraaound Catheter 10F (for GE Systems) (10043342)

    Reg #: 3032391 · FEI: 3002299608 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Medline ReNewal
    Registration Number
    3032391
    FEI Number
    3002299608
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1500 NE Hemlock Avenue
    City
    Redmond
    State
    OR
    ZIP
    97756
    Country
    US

    Regulatory Submissions

    510(k) Number
    K243101

    Owner / Operator

    Firm Name
    Medline ReNewal
    Operator Number
    9033518
    Address
    1500 NE Hemlock Avenue, --
    City
    Redmond
    State
    OR
    Postal Code
    97756
    Country
    US
    Correspondent
    Stephanie Augsburg

    Products

    Device Name Product Code
    Reprocessed Intravascular Ultrasound Catheter OWQ
    Catheter, Ultrasound, Intravascular OBJ

    Proprietary Names

    Medline ReNewal Reprocessed Siemens ACUSON AcuNav Ultraaound Catheter 10F (for GE Systems) (10043342) Medline ReNewal Reprocessed Siemens ACUSON AcuNav Ultrasound Catheter 10F (for Siemens Systems) (08255790)

    Establishment Types

    Reprocess Single-Use Device