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    K Number
    K983366
    Device Name
    TRIP TONOMETRY CATHETER, 16F
    Manufacturer
    DATEX-ENGSTROM, INC.
    Date Cleared
    1998-12-23

    (90 days)

    Product Code
    KNT,CBR,CCK
    Regulation Number
    876.5980
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TRIP TONOMETRY CATHETER, 16F

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

    The Trip® Tonometry Catheter, 16 F (with stopcock) is used for the determination of regional PCO2 (PrCO>) and intramucosal pH (pHi) of the gastric mucosal tissue. This catheter is also used as a gastrointestinal tract access device for connecting the Tonocap™ monitor. The sampling line and biofilter (which are separate from the device) serve as a means of connecting the catheter to the Tonocap™ monitor and as a transducer protector to prevent patient cross-contamination and to prevent monitor damage, respectively. Since it incorporates a vented gastric sump, the catheter is also used for feeding and/or decompression or aspiration of the contents of the stomach.

    The device is indicated for use in surgical/operating room patients, intensive care unit patients, emergency/trauma patients and hospital patients with suspected mesenteric ischemia

    The Trip® Tonometry Catheter, 16 F (with biofilter and sampling line) is used for the determination of regional PCO2 (PrCO2) and intramucosal pH (pHi) of the gastric mucosal tissue when used as a gastrointestinal tract access device for connecting the Tonocap™ monitor. The sampling line and biofilter serve as a means of connecting the catheter to the Tonocap™ monitor and as a transducer profector to prevent patient cross-contamination and to prevent monitor damage, respectively. Since it incorporates a vented gastric sump, the catheter is also used for feeding and/or decompression or aspiration of the contents of the stomach.

    The device is indicated for use in surgical/operating room patients, intensive care unit patients, emergency/trauma patients and hospital patients with suspected mesenteric ischemia

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device (TRIP Tonometry Catheter). It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and thus can be marketed.

    Therefore, I cannot provide the requested information based on the given text.

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