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

    LOCALMED INFUSION CATHETER

    K Number: K935349 · Decision Oct 18, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    147
    Registration Numbers
    147
    Same Product Code
    174
    Applicant Total
    5
    Review Days
    347

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    Basic Information

    Device Name
    LOCALMED INFUSION CATHETER
    K Number
    K935349
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Localmed, Inc.
    Date Received
    November 5, 1993
    Decision Date
    October 18, 1994
    Product Code
    KRA
    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
    KRA Catheter, Continuous Flush

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    Other Clearances by Localmed, Inc.

    K Number Device Name
    K980957 KAPLAN-SIMPSON INFUSASLEEVE II
    K972175 INFUSASLEEVE IIA (IS-2A)
    K952317 Kaplan-Simpson InfusaSleeve II Catheter
    K950615 KAPLAN-SIMPSON INFUSASLEEVE CATHETER