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

    SUBCLAVIAN LEAD INTRODUCER SYS

    K Number: K843642 · Decision Oct 23, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    273
    Registration Numbers
    273
    Same Product Code
    701
    Applicant Total
    9
    Review Days
    36

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    Basic Information

    Device Name
    SUBCLAVIAN LEAD INTRODUCER SYS
    K Number
    K843642
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Xanmed Corp.
    Date Received
    September 17, 1984
    Decision Date
    October 23, 1984
    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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    Other Clearances by Xanmed Corp.

    K Number Device Name
    K864623 OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KIT
    K844595 ORTHOPEDIC CUSTOM SURGICAL KIT
    K844596 EMERGENCY ROOM & MINOR OFFICE PROCEDURE CUSTOM KIT
    K844593 CARDIOVASCULAR CUSTOM SURGICAL KIT
    K844594 NEURO CUSTOM SURGICAL KIT
    K851906 SURGICAL EYE PACK
    K844597 MISCELLANEOUS GENERAL SURGICAL CUSTOM KIT
    K843641 CATHETER INTRODUCER SYSTEM