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510(k) Data Aggregation

    K Number
    K971613
    Device Name
    SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBING/SIL-TEC RADIOPAQUE TUBING
    Manufacturer
    TECHNICAL PRODUCTS, INC.
    Date Cleared
    1997-05-22

    (20 days)

    Product Code
    MIB
    Regulation Number
    874.3620
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The purchaser should thoroughly test products made in part or otherwise incorporating Sil-Tec medical grade tubing to determine the acceptability of the products performance in a specific application

    Applications for Tubing include :

    • Stillcone tubing has been used in artificial external or l .. internal blood circulatory systems where temporary substitution is needed for the heart, lungs, and arieriovenous system
    • 2 Blood transfusions
    • Suction drainage of surgical wounds 3
    • Temporary tube gastrostomy following abdominal surgery 4
    • Connecting glass tubing of different bores 5
    Device Description

    Sil-Tec Medical Grade Tubing

    AI/ML Overview

    This document is a marketing clearance letter from the FDA for a medical device called "Sil-Tec Medical Grade Tubing." It does not contain information about acceptance criteria or a study proving device performance in the way a typical medical device study report would.

    Therefore, I cannot provide the requested information. This letter is a regulatory clearance, not a study report.

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