BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Selectra IC – 90 – 69

    Reg #: 9610139 · FEI: 3002806500 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    31
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BIOTRONIK SE & CO. KG
    Registration Number
    9610139
    FEI Number
    3002806500
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    WOERMANNKEHRE 1
    City
    BERLIN
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K240787

    Owner / Operator

    Firm Name
    BIOTRONIK SE & CO. KG
    Operator Number
    9018331
    Address
    6024 Jean Road
    City
    Lake Oswego
    State
    OR
    Postal Code
    97035
    Country
    US

    US Agent

    Business Name
    BIOTRONIK, Inc.
    Contact Name
    Jon Brumbaugh
    Address
    6024 Jean Rd
    City
    Lake Grove
    State
    OR
    ZIP
    97035
    Country
    US
    Email
    [email protected]
    Phone
    503 9707014

    Products

    Device Name Product Code
    Catheter, Percutaneous DQY

    Proprietary Names

    Selectra IC – 90 – 69 Selectra 3D-55-32 Selectra 3D-65-32 Selectra IC – 50 – 69 Selectra Right – 45 Selectra Straight – 45 Selectra Extended Hook – 45 Selectra 3D-40-42 Selectra MPEP – 55 Selectra Extended Hook – 55 Selectra BIO2 – 45 Selectra 3D-65-42 Selectra Slitter Tool Selectra Amplatz 6 – 55 Selectra Hook – 45 Selectra 3D-55-39 Selectra Multipurpose Hook – 45 Selectra Accessory Kit Selectra Straight – 55 Selectra IC – 90 – 59 Selectra MPEP – 45 Selectra Hook – 55 Selectra 3D-40-39 Selectra Right – 55 Selectra 3D-40-32 Selectra 3D-65-39 Selectra BIO2 – 55 Selectra Multipurpose Hook – 55 Selectra IC – 50 – 59 Selectra 3D-55-42 Selectra Amplatz 6 – 45

    Establishment Types

    Manufacture Medical Device