BEUDAMED
    FDA Registration Active 🇺🇸 United States

    APRO 55 Intermediate Catheter

    Reg #: 3014211783 · FEI: 3014211783 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    ALEMBIC LLC
    Registration Number
    3014211783
    FEI Number
    3014211783
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    627 National Ave.
    City
    Mountain View
    State
    CA
    ZIP
    94043
    Country
    US

    Regulatory Submissions

    510(k) Number
    K234115

    Owner / Operator

    Firm Name
    Alembic LLC
    Operator Number
    10056521
    Address
    627 National Ave.
    City
    Mountain View
    State
    CA
    Postal Code
    94043
    Country
    US
    Correspondent
    Lisa Yen

    Products

    Device Name Product Code
    Catheter, Percutaneous, Neurovasculature QJP
    Catheter, Percutaneous DQY

    Proprietary Names

    APRO 55 Intermediate Catheter APRO 55 Catheter

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device