BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ASEPT

    Reg #: 3013666218 · FEI: 3013666218 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    PFM Medical, Inc
    Registration Number
    3013666218
    FEI Number
    3013666218
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1916 Palomar Oaks Way, Suite 150
    City
    Carlsbad
    State
    CA
    ZIP
    92008
    Country
    US

    Regulatory Submissions

    510(k) Number
    K241278

    Owner / Operator

    Firm Name
    PFM MEDICAL, INC
    Operator Number
    9052164
    Address
    1916 Palomar Oaks Way, Suite 150
    City
    Carlsbad
    State
    CA
    Postal Code
    92008
    Country
    US
    Correspondent
    Jiaye Jho

    Products

    Device Name Product Code
    Catheter, Retention Type, Balloon EZL
    Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling PNG

    Proprietary Names

    ASEPT

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device