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

    EMCEE INTRODUCER SHEATH, DILATOR, OBTURATOR, INTRODUCER SET

    K Number: K980504 · Decision Aug 7, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    273
    Registration Numbers
    273
    Same Product Code
    701
    Applicant Total
    2
    Review Days
    179

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    Basic Information

    Device Name
    EMCEE INTRODUCER SHEATH, DILATOR, OBTURATOR, INTRODUCER SET
    K Number
    K980504
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Schneider/Namic
    Date Received
    February 9, 1998
    Decision Date
    August 7, 1998
    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 Schneider/Namic

    K Number Device Name
    K983039 EMCEE INFUSION INTRODUCER SHEATH, EMCEE INFUSION INTRODUCER SET DILATOR, EMCEE INFUSION INTRODUCER SHEATH SET, EMCEE INF