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510(k) Data Aggregation

    K Number
    K965222
    Device Name
    MICROJECT MODEL PCA-1
    Manufacturer
    MICROJECT, INC.
    Date Cleared
    1997-06-19

    (170 days)

    Product Code
    MEB,MEA
    Regulation Number
    880.5725
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROJECT, INC.

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

    The indications for use of the MicroJect Model PCA-1 Driver is in the field of pain management. The Driver and associated, sterile Cassettes have been designed for the infusion of medications which are used to control pain. In addition to use by health care professionals, it is also indicated to be used by the patient for infusion of pain medications on an as-needed basis (patient controlled analgesia). The system is indicated for infusion of pain medications into intravenous, subcutaneous, and epidural access routes from standard drug containers, including flexible solution bags and syringes.

    Device Description

    MicroJect Model PCA-1

    AI/ML Overview

    This document is a 510(k) clearance letter for the MicroJect Model PCA-1 infusion pump. It does not contain information about acceptance criteria or a study proving device performance against such criteria. The letter confirms that the device is substantially equivalent to legally marketed predicate devices.

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

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