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

    SOFTOUCH INTRODUCER W/HEMOSTASIS VALVE & SIDEPORT

    K Number: K884159 · Decision Feb 22, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    273
    Registration Numbers
    273
    Same Product Code
    701
    Applicant Total
    7
    Review Days
    141

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    Basic Information

    Device Name
    SOFTOUCH INTRODUCER W/HEMOSTASIS VALVE & SIDEPORT
    K Number
    K884159
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Mallinckroot, Inc.
    Date Received
    October 4, 1988
    Decision Date
    February 22, 1989
    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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