BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Pleural Dynamics, Inc.

    Reg #: 3029300753 · FEI: 3029300753 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    0
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Pleural Dynamics, Inc.
    Registration Number
    3029300753
    FEI Number
    3029300753
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    952 Medina Road
    City
    Wayzata
    State
    MN
    ZIP
    55391
    Country
    US

    Regulatory Submissions

    510(k) Number
    K231096

    Owner / Operator

    Firm Name
    Pleural Dynamics, Inc.
    Operator Number
    10088649
    Address
    952 Medina Road
    City
    Wayzata
    State
    MN
    Postal Code
    55391
    Country
    US
    Correspondent
    John Streeter

    Products

    Device Name Product Code
    Catheter, Ventricular, General & Plastic Surgery GBS
    Shunt, Peritoneal KPM

    Establishment Types

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