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

    CEREGLIDE 92 Intermediate Catheter

    K Number: K230726 · Decision Nov 29, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    91
    Applicant Total
    8
    Review Days
    258

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    Basic Information

    Device Name
    CEREGLIDE 92 Intermediate Catheter
    K Number
    K230726
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cerenovus, Inc.
    Date Received
    March 16, 2023
    Decision Date
    November 29, 2023
    Product Code
    QJP
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QJP Catheter, Percutaneous, Neurovasculature

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    Other Clearances by Cerenovus, Inc.

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    K221930 CEREGLIDE 71 Intermediate Catheter
    K221934 CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set