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510(k) Data Aggregation

    K Number
    K252122

    Validate with FDA (Live)

    Device Name
    DCwire Micro-guidewire
    Manufacturer
    Shanghai Achieva Medical Suzhou Co., Ltd.
    Date Cleared
    2026-03-16

    (252 days)

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

    The DCwire Micro-guidewire is intended for general intravascular use, including neuro and peripheral vasculature. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neuro vasculature.

    Device Description

    The DCwire™ Micro-guidewire is a single-use device with a shapeable tip, used to gain intravascular access and facilitate the positioning and exchange of interventional devices in small diameter, tortuous vasculature for peripheral and neuro diagnostic and interventional procedures. The Micro-guidewire can be torqued to facilitate navigation through the vasculature.

    DCwire™ Micro-guidewire comes in three stiffness profiles: Soft, Standard, and Support.

    AI/ML Overview

    N/A

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