BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Selectra 3D-65-39

    Reg #: 1028232 · FEI: 1028232 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    31
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BIOTRONIK, INC.
    Registration Number
    1028232
    FEI Number
    1028232
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    6024 JEAN RD.
    City
    LAKE OSWEGO
    State
    OR
    ZIP
    97035
    Country
    US

    Regulatory Submissions

    510(k) Number
    K240787

    Owner / Operator

    Firm Name
    BIOTRONIK, INC.
    Operator Number
    1028232
    Address
    6024 JEAN RD., --
    City
    Lake Oswego
    State
    OR
    Postal Code
    97035
    Country
    US
    Correspondent
    JON - BRUMBAUGH

    Products

    Device Name Product Code
    Catheter, Percutaneous DQY

    Proprietary Names

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

    Establishment Types

    Repack or Relabel Medical Device