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510(k) Data Aggregation

    K Number
    K252027
    Device Name
    Vertex(TM) Catheter
    Manufacturer
    Jupiter Endovascular
    Date Cleared
    2025-09-12

    (74 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K160254
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Vertex™ Catheter is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions.

    Device Description

    Jupiter Endovascular's Vertex™ Catheter is a single-use catheter consisting of a multilayer shaft, a hemostatic valve, and an included locking obturator ("dilator"). The effective length of the catheter is coated to improve lubricity. The handle of the catheter includes a flush line, a fixation line for fixation control, and a hemostatic valve. The catheter shaft and obturator bodies are radiopaque. The distal tip of the catheter has a non-radiopaque region that is no more than 5 mm in length. The device is packaged as sterile and is for single use only.

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