BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PleuraFlow System with FlowGlide 32FR, PFFG3-32

    Reg #: 3008782989 · FEI: 3008782989 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    9
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    CLEARFLOW, INC
    Registration Number
    3008782989
    FEI Number
    3008782989
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    16 Technology Drive. Suite 150
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K203394

    Owner / Operator

    Firm Name
    ClearFlow, Inc.
    Operator Number
    10034650
    Address
    16 Technology Drive, Suite 150
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US
    Correspondent
    Ken Chesnin

    Products

    Device Name Product Code
    Catheter, Irrigation GBX
    Wound Drain Catheter System OTK

    Proprietary Names

    PleuraFlow System with FlowGlide 32FR, PFFG3-32 PleuraFlow System with FlowGlide Right Angle 32FR, PFFG3-32 RA PleuraFlow System with FlowGlide 28FR, PFFG3-28 PleuraFlow System with FlowGlide 24FR, PFFG3-24 PleuraFlow System with FlowGlide 20FR, PFFG3-20 PleuraFlow System with FlowGlide 24FR XDL, PFFG3-24 XDL PleuraFlow System with FlowGlide Right Angle 28FR, PFFG3-28 RA PleuraFlow System with FlowGlide 20FR XDL, PFFG3-20 XDL PleuraFlow System with FlowGlide Right Angle 24FR, PFFG3-24 RA

    Establishment Types

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