BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    OPN NC PTCA Dilatation Catheter

    Reg #: 3013634084 · FEI: 3013634084 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SIS MEDICAL AG
    Registration Number
    3013634084
    FEI Number
    3013634084
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Hungerbueelstr. 12A
    City
    Frauenfeld Thurgau
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K212393

    Owner / Operator

    Firm Name
    SIS Medical AG
    Operator Number
    10086262
    Address
    Hungerbueelstr. 12A
    City
    Frauenfeld
    State
    Thurgau
    Postal Code
    8500
    Country
    CH
    Correspondent
    Elsa Roxlau

    US Agent

    Business Name
    CardioMed Device Consultants, LLC
    Contact Name
    SEMIH OKTAY
    Address
    1783 FOREST DRIVE, NO. 254
    City
    Annapolis
    State
    MD
    ZIP
    21401
    Country
    US
    Email
    [email protected]
    Phone
    410 6742060

    Products

    Device Name Product Code
    Catheters, Transluminal Coronary Angioplasty, Percutaneous LOX

    Proprietary Names

    OPN NC PTCA Dilatation Catheter

    Establishment Types

    Manufacture Medical Device