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

    SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS

    K Number: K112407 · Decision Feb 9, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    273
    Registration Numbers
    273
    Same Product Code
    701
    Applicant Total
    20
    Review Days
    171

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    Basic Information

    Device Name
    SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS
    K Number
    K112407
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smiths Medical MD, Inc.
    Date Received
    August 22, 2011
    Decision Date
    February 9, 2012
    Product Code
    DYB
    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
    DYB Introducer, Catheter

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