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510(k) Data Aggregation

    K Number
    K260942

    Validate with FDA (Live)

    Date Cleared
    2026-04-07

    (18 days)

    Product Code
    Regulation Number
    870.1340
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K260163

    Validate with FDA (Live)

    Date Cleared
    2026-02-19

    (30 days)

    Product Code
    Regulation Number
    870.1340
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The AuST CSP Introducer is intended for the introduction of diagnostic and therapeutic devices into the human vasculature for intracardiac placements. Do not use this device for neural placements.

    Device Description

    The AuST CSP Introducer is a single-use percutaneous catheter intended to provide a pathway through which diagnostic and therapeutic devices are introduced in the human vasculature. The catheter is not intended for neural placements.

    The AuST CSP Introducer product family consists of a variety of configurations to accommodate different anatomies and/or devices being introduced into the human vasculature. Each of the sheaths in the product family is comprised of a braid-reinforced catheter shaft, deflectable segment, radiopaque distal tip, a handle with a 3-way stopcock for flushing and aspiration, and a hemostasis valve to prevent air and fluid leakage.

    AI/ML Overview

    N/A

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