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

    MODIFIED TELEFLEX MEDICAL INTRODUCER CATHETER

    K Number: K861951 · Decision Jun 19, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    273
    Registration Numbers
    273
    Same Product Code
    701
    Applicant Total
    10
    Review Days
    30

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    Basic Information

    Device Name
    MODIFIED TELEFLEX MEDICAL INTRODUCER CATHETER
    K Number
    K861951
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Teleflex, Inc.
    Date Received
    May 20, 1986
    Decision Date
    June 19, 1986
    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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