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

    RIVETTI-LEVINSON INSTRALUMINAL SHUNT

    K Number: K972261 · Decision Sep 15, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    104
    Registration Numbers
    104
    Same Product Code
    400
    Applicant Total
    12
    Review Days
    90

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    Basic Information

    Device Name
    RIVETTI-LEVINSON INSTRALUMINAL SHUNT
    K Number
    K972261
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Integra Neurocare, LLC
    Date Received
    June 17, 1997
    Decision Date
    September 15, 1997
    Product Code
    DWF
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

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    Other Clearances by Integra Neurocare, LLC

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    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
    K971617 ENDOSCOPIC VENTRICULAR CATHETER
    K970983 PERITONEAL/CARDIAC CATHETER
    K970658 LUMBAR DRAINAGE ACCESSORY KIT
    K964371 SHUNT TAP WITH ICP MONITORING ACCESS PORT
    K961859 NOVUS STANDARD AND PEDIATRIC VALVES
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