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510(k) Data Aggregation

    K Number
    K963214
    Device Name
    CORDIS ST STEERABLE GUIDEWIRE
    Manufacturer
    CORDIS CORP.
    Date Cleared
    1996-11-13

    (89 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K953760,K881897
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Cordis ST 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 ST Steerable Guidewire incorporates a stainless steel corewire and radiopaque coil. The shaft is coated with PTFE.

    AI/ML Overview

    This document describes a premarket notification for a medical device (Cordis ST Steerable Guidewire). It does not contain information about software or AI, nor does it detail a study involving acceptance criteria for device performance. Instead, it focuses on general device description, classification, and biocompatibility.

    Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. These details are typically found in documents related to performance testing, often for software-based medical devices or devices undergoing specific clinical trials.

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