BEUDAMED
    FDA Registration Active 🇺🇸 United States

    1.5MM DEK W/CVD INTRODUCER ASM

    Reg #: 2648045 · FEI: 2648045 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    EDWARDS LIFESCIENCES TECHNOLOGY SARL
    Registration Number
    2648045
    FEI Number
    2648045
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    STATE ROAD 402, KM 1.4, Industrial Park
    City
    ANASCO
    State
    PR
    ZIP
    00610
    Country
    US

    Regulatory Submissions

    510(k) Number
    K013513

    Owner / Operator

    Firm Name
    Edwards Lifesciences LLC
    Operator Number
    9040666
    Address
    One Edwards Way
    City
    Irvine
    State
    CA
    Postal Code
    92614
    Country
    US
    Correspondent
    Denny Kouri

    Products

    Device Name Product Code
    Arthroscope HRX

    Proprietary Names

    1.5MM DEK W/CVD INTRODUCER ASM 6"(1.85MM)DEKOMPRESSOR KIT 1.5mm DEKOMPRESSOR KIT INTRODUCER W/RND TIP STYLET 1MM DEKOMPRESSOR KIT 13G CANNULA W/BEVEL TIP STYLET 3IN (1MM) DEKOMPRESSOR KIT DEK INTRODUCER CANNULA W/STYLT 1.5mm DEKOMPRESSOR KIT (9") 6" (2.4MM) DEKOMPRESSOR KIT 15G CANNULA W/BEVEL TIP STYLET DEK CUR INTRO CANNULA W/STYLET

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)