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510(k) Data Aggregation

    K Number
    K070372
    Device Name
    GOPHER 2F SUPPORT CATHETER, MODEL 5600 AND GOPHER 3F SUPPORT CATHETER, MODEL 5610
    Manufacturer
    VASCULAR SOLUTIONS, INC.
    Date Cleared
    2007-06-01

    (113 days)

    Product Code
    DQY,DOY
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K052258,K060327,K051772
    Predicate For
    K083313,K091345,K101117
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Gopher Support Catheter is intended to be used in conjunction with steerable guidewires in order to access discreet regions of the arterial and/or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to subselectively infuse/deliver diagnostic or therapeutic agents.

    Device Description

    The Gopher catheter is available in two sizes-2F and 3F. Each catheter assembly has a polymeric outer layer and Nitinol middle layer that extend the length of the catheter. a porfilerie oud, the Nitinol tubing is laser cut and is lined with a PTFE/polyimide inner layer. To provide a radiographic means of locating the tip, the 2F size has a radiopaque markerband near the distal tip and the 3F distal tip is a segment of threaded, radiopaque stainless steel. Each catheter has printed positioning marks at 95cm and 105cm from the catheter's distal tip, a luer hub and strain relief on the proximal end, and an adjustable torque device near the proximal end. Each Gopher catheter model is compatible with ≥6F guide catheters and ≤0.014" guidewires and has a working length of approximately 135cm. The Gopher catheter is provided sterile and intended for a single use.

    AI/ML Overview

    The provided text describes a medical device (Gopher™ Support Catheter) and its 510(k) submission, confirming its substantial equivalence to predicate devices based on non-clinical testing. This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of an AI-powered diagnostic or assistive device.

    The document primarily focuses on establishing substantial equivalence for a physical medical catheter through bench testing and biocompatibility assessments, not on the performance of a software algorithm or AI.

    Therefore, I cannot provide the requested information in the format of a table or answer the specific questions related to AI device performance, sample sizes, ground truth establishment, or clinical studies involving human readers and AI. The document explicitly states: "Clinical evaluations were not required for this device."

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