BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Duette™ Dual Balloon Catheter

    Reg #: 3009425008 · FEI: 3009425008 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    POIESIS MEDICAL, LLC
    Registration Number
    3009425008
    FEI Number
    3009425008
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    151 Fern Street Suite 1
    City
    JUPITER
    State
    FL
    ZIP
    33458
    Country
    US

    Regulatory Submissions

    510(k) Number
    K941488

    Owner / Operator

    Firm Name
    Poiesis Medical, LLC
    Operator Number
    10041064
    Address
    151 Fern Street, Suite 1
    City
    Jupiter
    State
    FL
    Postal Code
    33458
    Country
    US
    Correspondent
    Gregory D Wiita

    Products

    Device Name Product Code
    Catheter, Retention Type, Balloon EZL

    Proprietary Names

    Duette™ Dual Balloon Catheter Duette™ Dual Balloon Catheter Kit

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility