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510(k) Data Aggregation

    K Number
    K251668

    Validate with FDA (Live)

    Device Name
    SurfRider 13 Microcatheter
    Manufacturer
    Kaneka Americas Holding, Inc.
    Date Cleared
    2026-01-05

    (220 days)

    Product Code
    QJP
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Neurology
    Age Range
    All
    Reference & Predicate Devices
    K202318,K210230
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SurfRider 13 Microcatheter is intended for the introduction of interventional devices, such as embolic coils, or diagnostic agents into the neurovasculature.

    Device Description

    The SurfRider 13 Microcatheter is a single-lumen microcatheter with a gradual stiffness change from tip to proximal end, reinforced with a metal braid to facilitate delivery to distal vessels and to serve as a delivery path of contrast media, embolic agents and coils. The distal end has two radiopaque markers to facilitate fluoroscopic visualization, and two types of tips: a straight tip and a pre-shaped tip. The proximal end of the Microcatheter incorporates a standard luer adaptor to facilitate the attachment of accessories. The outer surface of the Microcatheter has a hydrophilic coating to increase lubricity. The Microcatheter is designed to be introduced over a steerable guidewire into the vasculature.

    AI/ML Overview

    N/A

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