BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ventricle Mannequin, 120cc

    Reg #: 1649139 · FEI: 3002406063 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    18
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    KDL MEDICAL, INC.
    Registration Number
    1649139
    FEI Number
    3002406063
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    800 E Campbell Rd Ste 252
    City
    RICHARDSON
    State
    TX
    ZIP
    75081
    Country
    US

    Regulatory Submissions

    510(k) Number
    K020233

    Owner / Operator

    Firm Name
    KDL MEDICAL, INC. dba CHASE MEDICAL
    Operator Number
    9028011
    Address
    800 E. Campbell Rd., Suite 252
    City
    Richardson
    State
    TX
    Postal Code
    75081
    Country
    US
    Correspondent
    JACKIE LAFOLLETTE

    Products

    Device Name Product Code
    Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene DXZ

    Proprietary Names

    Ventricle Mannequin, 120cc SVR System with 90cc Mannequin SVR System with 80cc Mannequin Ventricle Mannequin, 130cc Ventricle Mannequin, 85cc Ventricle Mannequin, 80cc SVR System with 130cc Mannequin SVR System with 100cc Mannequin SVR System with 110cc Mannequin SVR System with 120cc Mannequin Ventricle Mannequin, 90cc SVR System with 140cc Mannequin Ventricle Mannequin, 110cc Ventricle Mannequin, 150cc SVR System with 85cc Mannequin Ventricle Mannequin, 100cc Ventricle Mannequin, 140cc SVR System with 150cc Mannequin

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198