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

    VASCULAR PROBE, VASCULAR PROBE ES

    K Number: K130896 · Decision Apr 24, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    19
    Applicant Total
    9
    Review Days
    23

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    Basic Information

    Device Name
    VASCULAR PROBE, VASCULAR PROBE ES
    K Number
    K130896
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4475
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Synovis Life Technologies, Inc.
    Date Received
    April 1, 2013
    Decision Date
    April 24, 2013
    Product Code
    DWP
    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
    DWP Dilator, Vessel, Surgical

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