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

    SHUNT TAP WITH ICP MONITORING ACCESS PORT

    K Number: K964371 · Decision Jan 31, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    69
    Same Product Code
    257
    Applicant Total
    12
    Review Days
    91

    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
    SHUNT TAP WITH ICP MONITORING ACCESS PORT
    K Number
    K964371
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5550
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Integra Neurocare, LLC
    Date Received
    November 1, 1996
    Decision Date
    January 31, 1997
    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 Integra Neurocare, LLC

    K Number Device Name
    K002392 VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V
    K992006 NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33
    K981246 BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730)
    K973525 MAURICE WORLDWIDE SHUNT SYSTEM
    K972994 EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS
    K972261 RIVETTI-LEVINSON INSTRALUMINAL SHUNT
    K971617 ENDOSCOPIC VENTRICULAR CATHETER
    K970983 PERITONEAL/CARDIAC CATHETER
    K970658 LUMBAR DRAINAGE ACCESSORY KIT
    K961859 NOVUS STANDARD AND PEDIATRIC VALVES
    Search all 12 clearances from Integra Neurocare, LLC →