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510(k) Data Aggregation

    K Number
    K260544

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-03-20

    (30 days)

    Product Code
    Regulation Number
    870.1330
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K212268

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    FMD Peripheral Guidewires are intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral use only.

    Device Description

    The FMD Peripheral Guide Wire F-14 and F-18 are designed to facilitate the placement of interventional peripheral devices such as dilating balloon catheters, stent delivery systems and other peripheral artery diagnostic or therapeutic devices. The FMD Peripheral Guide Wire F-14 and F-18 in this submission are available in nominal diameters of 0.014 (F-14) and 0.018 (F-18) inches and nominal lengths from 190 cm to 300 cm. The FMD Peripheral Guide Wire F-14 and F-18 with a length of less than 300 cm are compatible exclusively with the FMD Guide Wire Extension, which can extend the guide wire length allowing for exchange of Over-The-Wire systems. The basic structure of the FMD Peripheral Guide Wire F-14 and F-18 consists of a stainless steel core wire and a stainless steel and platinum nickel coil assembly on the distal end of the device. The coil assembly is soldered to the core. The Pt-Ni radiopaque coil allows for visualization while using fluoroscopy. The proximal portion of the guide wire is coated with PTFE coating, and the distal portion is coated with a hydrophilic coating. The FMD Peripheral Guide Wire F-18 DP 25 is available with a pre-shaped tip configuration. All other models are available in straight tip configuration.

    AI/ML Overview

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