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510(k) Data Aggregation

    K Number
    K974387
    Device Name
    PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER SET PTS102, CAP, HIGH TEMPERATURE
    Manufacturer
    MICROWAVE MEDICAL SYSTEMS, INC.
    Date Cleared
    1999-09-01

    (649 days)

    Product Code
    KDJ
    Regulation Number
    876.5630
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The PDM3 is intended for use by Peritoneal Dialysis patients in moist-heat intraluminal disinfection of ONLY the MMS PTS102 Patient Transfer Set connector when mated with a Baxte UltraBag™ connector or with a MMS 190259 High Temperature Cap.

    The MMS PTS102 Transfer Set is intended for use by Peritoneal Dialysis Patients to connect between the patient's catheter and either:

    1. a Baxter UltraBag™ dialysate solution bag connector during a Peritoneal Dialysis Solution Exchange process, or
    2. a MMS High Temperature Cap (Model 190259) when the bag connector is removed.
    Device Description

    Not Found

    AI/ML Overview

    This FDA document is a 510(k) clearance letter for the PDM3, Peritoneal Dialysis Device and Accessories, and its Indications for Use statement. It does not contain any information regarding clinical studies, acceptance criteria, or performance data for the device.

    Therefore, I cannot provide the requested information. The letter only confirms that the device has been found substantially equivalent to a predicate device and can be marketed.

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