BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit

    K Number: K200807 · Decision Apr 29, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    69
    Same Product Code
    257
    Applicant Total
    2
    Review Days
    33

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit
    K Number
    K200807
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.5550
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Irras USA, Inc.
    Date Received
    March 27, 2020
    Decision Date
    April 29, 2020
    Product Code
    JXG
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JXG Shunt, Central Nervous System And Components

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (JXG), ordered by most recent decision date.

    Intellidrop

    FDA 510(k)
    FDA Class 2 ·Neurology

    Sophy Mini Monopressure Valve (SM1)

    FDA 510(k)
    FDA Class 2 ·Neurology

    EVAC-MRI

    FDA 510(k)
    FDA Class 2 ·Neurology

    Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology

    FDA 510(k)
    FDA Class 2 ·Neurology

    Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762)

    FDA 510(k)
    FDA Class 2 ·Neurology

    External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

    Other Clearances by Irras USA, Inc.

    K Number Device Name
    K231664 IRRAflow Active Fluid Exchange System (AFES)