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510(k) Data Aggregation

    K Number
    K093431
    Device Name
    CLEARWAY OTW MODEL 85912
    Manufacturer
    ATRIUM MEDICAL CORP.
    Date Cleared
    2010-04-20

    (167 days)

    Product Code
    DQY,DOY
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CLEARWAY OTW MODEL 85912

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

    For localized infusion or irrigation of various diagnostic and therapeutic agents into the peripheral vasculature. It is not indicated for use in the neurovasculature.

    Device Description

    ClearWay OTW catheter

    AI/ML Overview

    I apologize, but the provided text is a 510(k) clearance letter from the FDA for the Atrium Medical Corp. ClearWay OTW catheter. This document primarily focuses on regulatory approval based on "substantial equivalence" to a predicate device and does not contain information about acceptance criteria or specific study data to prove the device meets those criteria.

    Therefore, I cannot extract the requested information, such as acceptance criteria tables, sample sizes, expert qualifications, or details about standalone or MRMC studies, because this information is not present in the provided text. The document is a regulatory approval notice, not a clinical study report or a technical performance specification.

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