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510(k) Data Aggregation

    K Number
    K160303
    Device Name
    Reprocessed Polaris X Steerable Diagnostic EP Catheter
    Manufacturer
    Innovative Health, LLC.
    Date Cleared
    2016-05-10

    (96 days)

    Product Code
    NLH
    Regulation Number
    870.1220
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K052414,K003452,K924163
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K052414

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

    The Reprocessed Polaris X Steerable Diagnostic EP Catheter is intended for temporary use in electrophysiology studies for intracardiac stimulation (pacing) and/or recording of electrical potentials.

    Device Description

    The Reprocessed Polaris X Steerable Diagnostic EP Catheters are designed for use in intracardiac pacing and recording only. The catheters have been designed to carry electrical signals for the purpose of endocardial stimulation (pacing) or recording. The catheter is a uni-directional steerable catheter. The curve is actuated by means of a patented thumb-slide.

    AI/ML Overview

    This document is a 510(k) premarket notification for a reprocessed medical device, specifically an Electrophysiology (EP) Catheter. It does not contain information about an AI/ML device or a study comparing AI performance against acceptance criteria. Therefore, I cannot extract the requested information regarding AI device performance, sample sizes, expert qualifications, or MRMC studies.

    The document focuses on demonstrating substantial equivalence of the reprocessed catheter to existing predicate devices based on design, materials, function, intended use, and various functional and safety tests relevant to a reprocessed medical device.

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