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

    ENROUTE Transcarotid Neuroprotection System

    K Number: K153485 · Decision Mar 10, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    35
    Applicant Total
    5
    Review Days
    98

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    Basic Information

    Device Name
    ENROUTE Transcarotid Neuroprotection System
    K Number
    K153485
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Silk Road Medical, Inc.
    Date Received
    December 3, 2015
    Decision Date
    March 10, 2016
    Product Code
    NTE
    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
    NTE Temporary Carotid Catheter For Embolic Capture

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    Other Clearances by Silk Road Medical, Inc.

    K Number Device Name
    K221414 ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter
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