BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    Alcyone MEMS Cannula (AMC) System

    K Number: K150660 · Decision Apr 16, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    34

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    Basic Information

    Device Name
    Alcyone MEMS Cannula (AMC) System
    K Number
    K150660
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    882.4060
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alcyone Lifesciences, Inc.
    Date Received
    March 13, 2015
    Decision Date
    April 16, 2015
    Product Code
    HCD
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    HCD Cannula, Ventricular

    Similar 510(k) Clearances

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

    SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA

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    CAMINO VENTRICULAR NEEDLE

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    Other Clearances by Alcyone Lifesciences, Inc.

    K Number Device Name
    K172006 Alivio Ventricular Catheter and Flusher System (Alivio System)