BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SafeCross Transseptal Puncture And Introducer (TSP/I) System

    Reg #: 3021558379 · FEI: 3021558379 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    EAST END MEDICAL I LLC
    Registration Number
    3021558379
    FEI Number
    3021558379
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    10320 USA Today Way
    City
    Miramar
    State
    FL
    ZIP
    33025
    Country
    US

    Regulatory Submissions

    510(k) Number
    K203459

    Owner / Operator

    Firm Name
    East End Medical I LLC
    Operator Number
    10084179
    Address
    10320 USA Today Way
    City
    Miramar
    State
    FL
    Postal Code
    33025
    Country
    US
    Correspondent
    Brijeshwar Maini

    Products

    Device Name Product Code
    Introducer, Catheter DYB
    Catheter, Septostomy DXF

    Proprietary Names

    SafeCross Transseptal Puncture And Introducer (TSP/I) System

    Establishment Types

    Manufacture Medical Device