BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Intra-Operative Positioning System (IOPS®)

    Reg #: 3012154226 · FEI: 3012154226 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    CENTERLINE BIOMEDICAL
    Registration Number
    3012154226
    FEI Number
    3012154226
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4535 Renaissance Pkwy
    City
    Cleveland
    State
    OH
    ZIP
    44128
    Country
    US

    Regulatory Submissions

    510(k) Number
    K243842

    Owner / Operator

    Firm Name
    Centerline Biomedical
    Operator Number
    10061285
    Address
    4535 Renaissance Pkwy
    City
    Cleveland
    State
    OH
    Postal Code
    44128
    Country
    US
    Correspondent
    Carroll Martin

    Products

    Device Name Product Code
    Catheter, Percutaneous DQY
    Wire, Guide, Catheter DQX
    Computer, Diagnostic, Programmable DQK

    Proprietary Names

    Intra-Operative Positioning System (IOPS®)

    Establishment Types

    Manufacture Medical Device