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510(k) Data Aggregation

    K Number
    K252297

    Validate with FDA (Live)

    Device Name
    Toro 88 Superbore Catheter
    Manufacturer
    Toro Neurovascular, Inc.
    Date Cleared
    2026-01-16

    (177 days)

    Product Code
    QJP
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Neurology
    Age Range
    All
    Reference & Predicate Devices
    K240948
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Toro 88 Superbore Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

    Device Description

    The Toro 88 Superbore Catheter is a variable stiffness, single lumen catheter designed to introduce interventional devices into the vasculature. The catheter shaft design includes stainless steel and nitinol wires and polymers of varying durometers. The catheter incorporates an internal lubricious liner to facilitate its advancement over a steerable guidewire or microcatheter. To reduce friction during manipulation, a hydrophilic coating is applied to the distal exterior section of the catheter shaft. A single radiopaque tip marker provides visualization under fluoroscopy. The proximal end of the catheter includes a hub with Luer lock. The catheter is supplied sterile, for single use only.

    AI/ML Overview

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