BEUDAMED
    FDA Registration Active 🇺🇸 United States

    KDL MEDICAL, INC.

    Reg #: 1649139 · FEI: 3002406063 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    55
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    KDL MEDICAL, INC.
    Registration Number
    1649139
    FEI Number
    3002406063
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    800 E Campbell Rd Ste 252
    City
    RICHARDSON
    State
    TX
    ZIP
    75081
    Country
    US

    Regulatory Submissions

    510(k) Number
    K974568

    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
    Lavage, Jet FQH
    Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF
    Instruments, Surgical, Cardiovascular DWS
    Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene DXZ

    Proprietary Names

    Blower Mister TRIPOD Heart Stabilizer Nylon Blower/Occluder TRIPOD Heart Stabilizer Nylon with Blower TRIPOD Heart Stabilizer Med Metal with Blower Vessel Shunt, 2mm Tip,12mm Shaft Vessel Shunt, 1.75mm Tip,12mm Shaft Vessel Shunt, 1.25mm Tip,12mm Shaft Vessel Shunt, 4mm Plug,12mm Shaft Vessel Shunt, 2.5mm Tip,12mm Shaft Vessel Shunt, 1.5mm Tip,12mm Shaft Vessel Shunt, 10mm Tip,12mm Shaft Vessel Shunt, 2.5mm Plug, 30mm Shaft Vessel Shunt, 4mm Plug, 30mm Shaft Vessel Shunt, 2mm Plug, 30mm Shaft Vessel Shunt, 3mm Plug, 30mm Shaft Vessel Shunt, 3mm Plug,12mm Shaft Vessel Shunt, 2.25mm Tip, 12mm Shaft TRIPOD Heart Stabilizer Lt Metal FASTRACT VIPER Tubing Set TRIPOD Heart Stabilizer Nylon FASTRACT TRIPOD Heart Stabilizer Lt Metal w/Occluder TRIPOD Heart Stabilizer Nylon Occ FASTRACT VIPER II Apical Lift TRIPOD Heart Stabilizer Nylon FASTRACT +2cm TRIPOD Heart Stabilizer Nylon Texture VIPER II Heart Stabilizer FASTRACT Sternal Retractor TRIPOD Heart Stabilizer Medium Metal TRIPOD Heart Stabilizer Lt Mtl FASTRACT +4cm FASTRACT Suture Stay - Single TRIPOD Heart Stabilizer Med Metal FASTRACT TRIPOD Heart Stabilizer Lt Mtl FASTRACT +2cm VIPER Heart Stabilizer VIPER Heart Stabilizer, Universal Mount TRIPOD Heart Stabilizer Nylon w/Occluder FASTRACT Suture Stay - Double Disposable Platform Blades Ventricle Mannequin, 85cc SVR System with 140cc Mannequin SVR System with 130cc Mannequin Ventricle Mannequin, 130cc SVR System with 150cc Mannequin SVR System with 100cc Mannequin Ventricle Mannequin, 80cc Ventricle Mannequin, 140cc SVR System with 85cc Mannequin SVR System with 110cc Mannequin SVR System with 120cc Mannequin Ventricle Mannequin, 110cc Ventricle Mannequin, 90cc SVR System with 80cc Mannequin Ventricle Mannequin, 120cc SVR System with 90cc Mannequin Ventricle Mannequin, 100cc Ventricle Mannequin, 150cc

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198