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510(k) Data Aggregation

    K Number
    K252390

    Validate with FDA (Live)

    Device Name
    Telescope Guide Extension Catheter
    Manufacturer
    Medtronic Ireland
    Date Cleared
    2025-10-29

    (90 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K183353
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Telescope™ Guide Extension Catheter is intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.

    Device Description

    The Telescope™ Guide Extension Catheter is a single-lumen rapid exchange catheter designed to act as an extension to a traditional guide catheter. The Telescope™ Guide Extension Catheter is intended to be used with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.

    The Telescope™ Guide Extension Catheter device is 150cm in length and consists of a hydrophilic-coated single-lumen distal guide segment connected to a stainless-steel polytetrafluoroethylene (PTFE) coated proximal pushwire.

    The device is offered in two sizes 6F and 7F, with a hub at the proximal end of the pushwire that is used for device identification.

    AI/ML Overview

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