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510(k) Data Aggregation

    K Number
    K251097

    Validate with FDA (Live)

    Device Name
    V-DAC Catheter
    Manufacturer
    Vesalio, Inc.
    Date Cleared
    2026-01-06

    (271 days)

    Product Code
    QJP
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Neurology
    Age Range
    All
    Reference & Predicate Devices
    K211654,K183463
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The V-DAC Catheter is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the peripheral and neurovascular systems.

    Device Description

    The V-DAC Catheter consists of 1) Distal Access Catheter and 2) Peel-Away Introducer Sheath.

    The V-DAC Catheter is a single lumen, coil-reinforced, flexible, variable stiffness composite catheter. The catheter distal shaft has an external hydrophilic coating aimed at reducing friction during use. The distal end of the catheter shaft is radiopaque for fluoroscopic visualization, and the proximal end contains a luer hub that allows the insertion and guidance of microcatheters into a selected blood vessel in the neurovascular system. Complete dimensions of the catheter are included on the device label.

    The Peel-Away Introducer is an accessory provided with the catheter to aid in the delivery of the catheter.

    The V-DAC Catheter and a Peel-Away Introducer are packaged together, they are provided sterile, non-pyrogenic, and are intended for single use only.

    AI/ML Overview

    N/A

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