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

    HeartLight Deflectable Sheath

    K Number: K152310 · Decision Feb 24, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    47
    Same Product Code
    40
    Applicant Total
    5
    Review Days
    194

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    Basic Information

    Device Name
    HeartLight Deflectable Sheath
    K Number
    K152310
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1280
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardiofocus, Inc.
    Date Received
    August 14, 2015
    Decision Date
    February 24, 2016
    Product Code
    DRA
    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
    DRA Catheter, Steerable

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    Other Clearances by Cardiofocus, Inc.

    K Number Device Name
    K013201 CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR
    K013901 MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM)
    K011988 SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C
    K993834 SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C