BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    NC Gallant PTCA Dilatation Catheter

    Reg #: 3003084171 · FEI: 3003182398 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    MEDINOL LTD.
    Registration Number
    3003084171
    FEI Number
    3003182398
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8 Hartom Street Beck Tech Bldg. Har Hotzvim B,
    City
    Jerusalem
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K162434

    Owner / Operator

    Firm Name
    MEDINOL LTD.
    Operator Number
    9031416
    Address
    Kiryat Atidim, Bldg. 8
    City
    Tel Aviv
    State
    IL-TA
    Postal Code
    6158101
    Country
    IL

    US Agent

    Business Name
    CardioMed Device Consultants, LLC
    Contact Name
    H. Semih Oktay
    Address
    1783 Forest Drive #254
    City
    Annapolis
    State
    MD
    ZIP
    21401
    Country
    US
    Email
    [email protected]
    Phone
    410 6742060

    Products

    Device Name Product Code
    Catheters, Transluminal Coronary Angioplasty, Percutaneous LOX

    Proprietary Names

    NC Gallant PTCA Dilatation Catheter

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device