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

    Sentinel Cerebral Protection System

    K Number: DEN160043 · Decision Jun 1, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    254

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    Basic Information

    Device Name
    Sentinel Cerebral Protection System
    K Number
    DEN160043
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    870.1251
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Applicant
    Claret Medical, Inc.
    Date Received
    September 20, 2016
    Decision Date
    June 1, 2017
    Product Code
    PUM
    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
    PUM Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures

    Similar 510(k) Clearances

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

    Sentinel Cerebral Protection System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
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