BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DPX Introducer Set with Valved Tearaway Sheath

    Reg #: 3003289723 · FEI: 3003289723 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ALPHA MEDICAL INSTRUMENTS LLC
    Registration Number
    3003289723
    FEI Number
    3003289723
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    23455 Madero Ste B
    City
    MISSION VIEJO
    State
    CA
    ZIP
    92691
    Country
    US

    Regulatory Submissions

    510(k) Number
    K000313

    Owner / Operator

    Firm Name
    ALPHA MEDICAL INSTRUMENTS INC
    Operator Number
    9034270
    Address
    23455 MADERO, SUITE B
    City
    Mission Viejo
    State
    CA
    Postal Code
    92691
    Country
    US
    Correspondent
    Hideo - Tanaka

    Products

    Device Name Product Code
    Introducer, Catheter DYB

    Proprietary Names

    DPX Introducer Set with Valved Tearaway Sheath

    Establishment Types

    Repack or Relabel Medical Device