BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EMBOLX INC.

    Reg #: 3011660785 · FEI: 3011660785 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    EMBOLX INC.
    Registration Number
    3011660785
    FEI Number
    3011660785
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    530 Lakeside Dr Ste 150
    City
    Sunnyvale
    State
    CA
    ZIP
    94085
    Country
    US

    Regulatory Submissions

    510(k) Number
    K232536

    Owner / Operator

    Firm Name
    Embolx Inc.
    Operator Number
    10049613
    Address
    530 Lakeside Dr Ste 150
    City
    Sunnyvale
    State
    CA
    Postal Code
    94085
    Country
    US
    Correspondent
    Michael Allen

    Products

    Device Name Product Code
    Catheter, Intravascular, Diagnostic DQO
    Catheter, Intravascular Occluding, Temporary MJN

    Proprietary Names

    Soldier Microcatheter Embolx Microcatheter

    Establishment Types

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