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510(k) Data Aggregation

    K Number
    K962932
    Device Name
    CORDIS STABILIZER PLUS XS
    Manufacturer
    CORDIS CORP.
    Date Cleared
    1996-10-25

    (88 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K953760,K935997
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Cordis STABILIZER Plus XS Steerable Guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.

    Device Description

    The Cordis STABILIZER Plus XS Steerable Guidewire is an extra support version of the Cordis WIZDOM Steerable Guidewire. The extra support versions of the WIZDOM Steerable Guidewire utilize slightly larger diameter corewires and different tapers compared to the conventional WIZDOM guidewire in order to provide the extra support required for bulkier device (such as a stent) introduction.

    AI/ML Overview

    This document, K962932 for the Cordis STABILIZER™ Plus XS Steerable Guidewire, is a Premarket Notification (510(k)) summary. It details the device's intended use, classification, and comparison to predicate devices, but does not contain the acceptance criteria or a study proving the device meets said criteria.

    The information provided describes:

    • Device: Cordis STABILIZER™ Plus XS Steerable Guidewire
    • Intended Use: For use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.
    • Device Description: An extra support version of the Cordis WIZDOM Steerable Guidewire, utilizing slightly larger diameter corewires and different tapers for increased support.
    • Predicate Devices: Cordis WIZDOM Steerable Guidewire (K953760) and Meditech/Boston Scientific Platinum Plus™ Guidewire (K935997).
    • Biocompatibility: Stated to use the exact same materials as the currently marketed WIZDOM Steerable Guidewire.

    The document explicitly states: "Performance standards have not been established by the FDA under section 514 of the Food. Drug and Cosmetic Act." This indicates that there are no pre-defined performance acceptance criteria provided within this specific document, nor is there a study detailed to demonstrate meeting such criteria.

    Therefore, I cannot populate the requested table or answer the questions regarding study design, sample sizes, ground truth, or expert qualifications as this information is not present in the provided text. This 510(k) summary focuses on substantial equivalence to predicate devices rather than detailing a specific performance study with acceptance criteria.

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