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510(k) Data Aggregation

    K Number
    K201706
    Device Name
    KDL Micro catheter
    Manufacturer
    Shanghai Kindly Medical Instruments Co., Ltd.
    Date Cleared
    2021-07-22

    (395 days)

    Product Code
    DQY,KRA
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K190401,K173548,K082519
    Why did this record match?
    Device Name :

    KDL Micro catheter

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

    KDL Micro catheter is used to provide support, to facilitate the placement of guidewires in the peripheral and coronary vasculature, and can be used to exchange one guidewire for another. It is also intended to assist in the delivery of diagnostics, embolic, or therapeutic materials into peripheral and coronary vessels

    Device Description

    The KDL Micro catheter is available in two French configurations, 2.3F (proximal)/1.6F (distal) and 2.5F (proximal) /1.8F (distal), 110cm, 130cm, 180cm of effective lengths. The proposed device consists of Hub with luer connector, strain relief, catheter shaft, a radiopaque marker and soft tip. The catheter shaft and radiopaque marker consist of 3 layers, an outer layer of Eurelon or pebax tube containing BaSO4, a middle layer of stainless steel braid mesh and an inner layer of PTFE tube, in addition, the middle layer of radiopaque marker consist of Platinoiridium. The radiopaque marker at the distal tip to facilitate fluoroscopic visualization. The soft tip consists of 2 layers, an outer layer of pebax tube containing BaSO4, an inner layer of PTFE tube. The outer surface of the micro catheter shaft is coated with a hydrophilic coating designed to facilitate the introduction of the micro catheter into the vasculature.

    The distal tip of micro catheter is offered in straight (MCS) and swan neck (MCM) configurations.

    All models of the catheter are designed to accept a maximum guidewire diameter of 0.010 inch or 0.014 inch.

    AI/ML Overview

    The provided text is a 510(k) summary for the KDL Micro catheter. It describes the device, its intended use, comparison to predicate devices, and performance data from bench and biocompatibility testing. However, it does not contain information about an AI/ML powered device or a study involving human readers, expert ground truth adjudication, or statistical metrics like sensitivity, specificity, or AUC. Therefore, I am unable to fulfill the request based on the provided input.

    The document pertains to a Class II medical device (percutaneous catheter) and its substantial equivalence determination to previously cleared predicate devices. The performance data presented are for the physical and biological characteristics of the catheter, not the performance of an AI/ML algorithm.

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