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510(k) Data Aggregation

    K Number
    K964611
    Device Name
    TRANSEND GUIDEWIRE
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Date Cleared
    1997-01-28

    (71 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TRANSEND GUIDEWIRE

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

    The BSC Transend Steerable Guidewire with hydrophilic coating and accessories are intended for general intravascular use including the peripheral and neurovasculature.

    Device Description

    The BSC Transend Steerable Guidewire with hydrophilic coating and accessories are intended for general intravascular use including the peripheral and neurovasculature. The devices will be provided sterile, and are intended for one procedure use only. Testing and evaluation included tip tensile, tip flexibility, torque strength, torque response, coating adherance, coating extraction, lubricity testing, biocompatibility and in vivo testing.

    AI/ML Overview

    This document is a 510(k) Premarket Notification for a medical device (BSC Transend Guidewire) and not a study describing the acceptance criteria and performance of an AI/ML device. Therefore, the requested information based on AI/ML study characteristics (like sample size for test/training sets, expert ground truth, MRMC studies, etc.) cannot be extracted from the provided text.

    The document discusses the safety and effectiveness of a traditional medical device (a guidewire) based on various mechanical, material, and in vivo tests. It does not involve any AI or algorithmic performance evaluation.

    If you have a document describing an AI/ML device study, please provide that, and I will be able to answer your questions.

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