BEUDAMED
    FDA Registration Active 🇺🇸 United States

    KANEKA AMERICAS HOLDING INC

    Reg #: 3014758755 · FEI: 3014758755 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    KANEKA AMERICAS HOLDING INC
    Registration Number
    3014758755
    FEI Number
    3014758755
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    7979 Gateway Blvd
    City
    Newark
    State
    CA
    ZIP
    94560
    Country
    US

    Regulatory Submissions

    510(k) Number
    K251668

    Owner / Operator

    Firm Name
    KANEKA AMERICAS HOLDING INC
    Operator Number
    10095053
    Address
    7979 Gateway Blvd
    City
    Newark
    State
    CA
    Postal Code
    94560
    Country
    US

    Products

    Device Name Product Code
    Catheter, Continuous Flush KRA
    Catheter, Percutaneous, Neurovasculature QJP

    Proprietary Names

    Surfrider 13 Microcatheter

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility