BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Avalon Elite Vascular Access Kit

    Reg #: 8010762 · FEI: 3009649876 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    MAQUET CARDIOPULMONARY GmbH
    Registration Number
    8010762
    FEI Number
    3009649876
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Neue Rottenburger Strasse 37
    City
    Hechingen Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K081940

    Owner / Operator

    Firm Name
    Maquet Cardiopulmonary GmbH
    Operator Number
    8010762
    Address
    Kehler Strasse 31
    City
    Rastatt
    State
    Baden-Wurttemberg
    Postal Code
    76437
    Country
    DE
    Correspondent
    Tom Peters

    Products

    Device Name Product Code
    Dilator, Vessel, For Percutaneous Catheterization DRE

    Proprietary Names

    Avalon Elite Vascular Access Kit

    Establishment Types

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