Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K260130

    Validate with FDA (Live)

    Date Cleared
    2026-02-13

    (28 days)

    Product Code
    Regulation Number
    870.1330
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Willow 18 Guidewire is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neuro vasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.

    Device Description

    Like the predicate device, the Willow 18 Guidewire is a single-use product with a shapeable tip, used to gain intravascular access to facilitate the positioning and exchange of interventional devices in small diameter, tortuous vasculature for neuro and peripheral diagnostic and interventional procedures. The wire can be torqued to facilitate navigation through the vasculature. The Willow 18 Guidewire comes in two stiffness profiles: Soft and Standard.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1