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510(k) Data Aggregation

    K Number
    K991291
    Device Name
    STRETTA INFLATABLE BASKET CATHETER ELECTRODE WITH ASPIRATION
    Manufacturer
    CONWAY STUART MEDICAL, INC.
    Date Cleared
    1999-07-14

    (90 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    STRETTA INFLATABLE BASKET CATHETER ELECTRODE WITH ASPIRATION

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

    Indicated for coagulation of tissue
    These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.

    Device Description

    Conway Stuart Medical Model C8 Needle Inflatable Basket Catheter Electrode with Aspiration

    AI/ML Overview

    I'm sorry, but without further input, I cannot furnish an answer. The provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device called the "Stretta Model C8 Needle Inflatable Basket Catheter Electrode with Aspiration." This letter confirms the device's substantial equivalence to previously marketed devices and outlines regulatory responsibilities. However, it does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. Therefore, I cannot construct an answer based on the provided text.

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