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510(k) Data Aggregation

    K Number
    K073627
    Device Name
    FLEXOR EVAC ASPIRATION CATHETER
    Manufacturer
    COOK, INC.
    Date Cleared
    2008-03-04

    (69 days)

    Product Code
    QEZ,DXE,OEY
    Regulation Number
    870.5150
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K061958,K063371
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Intended for removal of fresh, soft thrombi/emboli from the peripheral arterial system.

    Device Description

    The Flexor Evac Aspiration Catheter is hydrophilically coated, Flexor® material with a radiopaque band. The device is supplied with a Tuohy-Borst side-arm adaptor, stopcock valve, rapid exchange dilator, and a 30 mL vacuum syringe. This device is available in various lengths and French sizes.

    AI/ML Overview

    This document is a 510(k) premarket notification for the Cook Flexor Evac Aspiration Catheter. It does not contain information about acceptance criteria or a study proving the device meets said criteria in the format requested. The document describes the device, its intended use, and lists types of tests performed (e.g., pressure rating, liquid leakage, tensile strength, animal study, biocompatibility) to assure reliable design and performance, but it does not provide specific acceptance values or detailed results for these tests. There is no information about a multi-reader multi-case (MRMC) comparative effectiveness study, standalone algorithm performance, ground truth establishment, or sample sizes for training or test sets in the context of an AI/ML device.

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