BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Lake Region Medical

    Reg #: 2126666 · FEI: 2126666 · Expires 2026
    View on FDA
    Products
    28
    Proprietary Names
    12
    Establishment Types
    3
    Classifications
    28

    Registration Details

    Registration Name
    Lake Region Medical
    Registration Number
    2126666
    FEI Number
    2126666
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    340 Lake Hazeltine Dr
    City
    CHASKA
    State
    MN
    ZIP
    55318
    Country
    US

    Regulatory Submissions

    510(k) Number
    K935198

    Owner / Operator

    Firm Name
    Lake Region Medical
    Operator Number
    2126666
    Address
    340 Lake Hazeltine Drive, --
    City
    Chaska
    State
    MN
    Postal Code
    55318
    Country
    US
    Correspondent
    Deko - Hussein

    Products

    Device Name Product Code
    Tubes, Gastrointestinal (And Accessories) KNT
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection GCA
    Catheter, Nephrostomy LJE
    Stent, Ureteral FAD
    Accessories, Catheter, G-U KNY
    Stylet For Catheter, Gastro-Urology EZB
    Endoscopic Guidewire, Gastroenterology-Urology OCY
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Wire, Guide, Catheter DQX
    Stylet, Ureteral EYA
    Catheter, Percutaneous DQY
    Device, Neurovascular Embolization HCG
    Catheter, Electrode Recording, Or Probe, Electrode Recording DRF
    Temporary Carotid Catheter For Embolic Capture NTE
    Computer, Diagnostic, Programmable DQK
    Unit, Phacofragmentation HQC
    Orthopedic Manual Surgical Instrument LXH
    Device, Biopsy, Endomyocardial DWZ
    System, Balloon, Intra-Aortic And Control DSP
    Catheter For Crossing Total Occlusions PDU
    Catheter, Coronary, Atherectomy MCX
    Catheter, Septostomy DXF
    Intracranial Neurovascular Stent NJE
    Accessories, Arthroscopic NBH
    Vitrectomy, Instrument Cutter MLZ
    Apparatus, Cautery, Radiofrequency, Ac-Powered HQR
    Dilator, Esophageal KNQ

    Proprietary Names

    K935198 K850829 Predicate III K914138 K000011 K770977 K935170 GLADIATOR GUIDEWIRE K080144 Infiniti Vision System (with I/A Tips (HQR being part of the System) Torque Device K011968

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device