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510(k) Data Aggregation

    K Number
    K163376
    Device Name
    Mikro-Cath Pressure Catheter
    Manufacturer
    Millar, Inc.
    Date Cleared
    2017-03-10

    (99 days)

    Product Code
    DXO
    Regulation Number
    870.2870
    Why did this record match?
    Applicant Name (Manufacturer) :

    Millar, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mikro-Cath Pressure Catheter is a single-use catheter intended to be used for medical research and diagnostic purposes. The catheter is indicated to measure cardiovascular, intracompartmental, and airway pressures in the human body. The catheter is used as a minimally invasive device under short term limited body contact (<24 hours).
    Device Description
    The Mikro-Cath Pressure Catheter is a single-use catheter intended to be used for medical research and diagnostic purposes. The catheter is indicated to measure cardiovascular, intracompartmental, and airway pressures in the human body. A pressure sensor is mounted at the distal tip of the catheter. The proximal end terminates in a connector. The sensor produces an electrical output signal which varies in direct proportion to the magnitude of sense pressure or sound.
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