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

    INFUSASLEEVE IIA (IS-2A)

    K Number: K972175 · Decision Aug 28, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    70
    Applicant Total
    5
    Review Days
    80

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    Basic Information

    Device Name
    INFUSASLEEVE IIA (IS-2A)
    K Number
    K972175
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5150
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Localmed, Inc.
    Date Received
    June 9, 1997
    Decision Date
    August 28, 1997
    Product Code
    QEY
    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
    QEY Mechanical Thrombolysis Catheter

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    Other Clearances by Localmed, Inc.

    K Number Device Name
    K980957 KAPLAN-SIMPSON INFUSASLEEVE II
    K952317 Kaplan-Simpson InfusaSleeve II Catheter
    K950615 KAPLAN-SIMPSON INFUSASLEEVE CATHETER
    K935349 LOCALMED INFUSION CATHETER