BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    Passeo-35 Xeo

    Reg #: 8043892 · FEI: 3002808050 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BIOTRONIK AG
    Registration Number
    8043892
    FEI Number
    3002808050
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ACKERSTRASSE 6
    City
    BULACH Zurich
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K250706

    Owner / Operator

    Firm Name
    BIOTRONIK AG
    Operator Number
    10024585
    Address
    Ackerstrasse 6
    City
    Buelach
    State
    Zurich
    Postal Code
    CH-8180
    Country
    CH

    US Agent

    Business Name
    BIOTRONIK, Inc.
    Contact Name
    Jon Brumbaugh
    Address
    6024 Jean Road
    City
    Lake Oswego
    State
    OR
    ZIP
    97035
    Country
    US
    Email
    [email protected]
    Phone
    888 3450374

    Products

    Device Name Product Code
    Catheters, Transluminal Coronary Angioplasty, Percutaneous LOX
    Catheter, Angioplasty, Peripheral, Transluminal LIT

    Proprietary Names

    Passeo-35 Xeo Passeo-14 Pantera LEO Passeo-18 Pantera Pro Oscar Multifunctional Catheter System

    Establishment Types

    Manufacture Medical Device