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510(k) Data Aggregation

    K Number
    K963171
    Device Name
    CINCH QR SGW EXTENSION
    Manufacturer
    CORDIS CORP.
    Date Cleared
    1996-11-07

    (85 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K914863,K953760
    Why did this record match?
    Reference Devices :

    K914863, K953760

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

    The Cordis CINCH® OR Steerable Guidewire Extension is designed to extend Cordis Steerable Guidewires so that a catheter can be exchanged for another catheter

    Device Description

    The CINCH® QR Steerable Guidewire Extension is a flexible stainless steel wire coated with DURAGLIDETM . The extension is 145 cm long and has a shaft diameter of 0.014 inches.

    AI/ML Overview

    This document is a 510(k) premarket notification for a medical device (Cordis CINCH® QR Steerable Guidewire Extension). It is not a study report demonstrating the device meets acceptance criteria, nor does it contain information about clinical performance or AI algorithm validation.

    Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on regulatory submission details like device description, intended use, and equivalence to predicate devices, and explicitly states that "Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act." and "Biocompatibility testing was not repeated".

    To answer your questions, I would need a different type of document, such as a clinical study report or a validation study for an AI-powered device.

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