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510(k) Data Aggregation

    K Number
    K112323
    Device Name
    CARDIA-CATH
    Manufacturer
    MILLAR INSTRUMENTS, INC.
    Date Cleared
    2011-10-18

    (67 days)

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

    MILLAR INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Monitoring combined pressure and electrical impedance (volume) in the cardiovascular system
    Device Description
    The Cath-Cath-Catheter is a disposable/single use, sterile pressure-volume catheter transducer that combines one or two pressure transducers and a series of electrodes mounted at various locations along the distal segment of the catheter body. It terminates in one electrical connection at the proximal end.
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    K Number
    K093111
    Device Name
    MIKRO-CATH, MODEL 825-0101
    Manufacturer
    MILLAR INSTRUMENTS, INC.
    Date Cleared
    2010-01-05

    (96 days)

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

    MILLAR INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mikro-Cath is a single-use cardiovascular catheter intended to be used for medical research and diagnostic purposes. The catheter is used to measure hemodynamic cardiac pressures in the hurnan body to allow physicians to better understand cardiac health. The catheter would be used as a minimally invasive device under short term limited body contact <24 hours. The typical application will be through the femoral artery with the use of an additional guiding catheter.
    Device Description
    The Mikro-Cath is a disposable/single use, sterile cardiovascular pressure catheter transducer for monitoring and measuring pressure anywhere in the cardiovascular system with an appropriately sized guide catheter.
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    K Number
    K013205
    Device Name
    MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000
    Manufacturer
    MILLAR INSTRUMENTS, INC.
    Date Cleared
    2002-07-02

    (280 days)

    Product Code
    DRQ, DRO
    Regulation Number
    870.2060
    Why did this record match?
    Applicant Name (Manufacturer) :

    MILLAR INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PCU-2000 Pressure Control Unit is a two-channel electrically isolated amplifier that is intended for use with Millar Mikro-Tip Pressure Catheters that have the standard medical sensitivity of 5 microvolts per mmHg of applied pressure and per volt of bridge excitation. The PCU-2000 provides an electrical interface between a physiological pressure transducer and a data acquisition module or medical monitor. It is intended for use in monitoring diagnostic pressures, such as noninvasive or invasive blood pressures, intracranial pressures, gastrointestinal pressures, esophageal pressures, urinary tract pressures, intrauterine pressures, intraocular pressures and other physiological pressures with similar ranges. It is intended for use in critical care areas in a hospital and in diagnostic centers in hospitals or medical clinics. It is intended for use by trained clinicians or research personnel
    Device Description
    The PCU-2000 Pressure Control Unit is a two-channel electrically isolated amplifier that is intended for use with Millar Mikro-Tip Pressure Catheters that have the standard medical sensitivity of 5 microvolts per mmHg of applied pressure and per volt of bridge excitation. The PCU-2000 provides an electrical interface between a physiological pressure transducer and a data acquisition module or medical monitor.
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    K Number
    K993694
    Device Name
    MIKRO-TIP ANGIOGRAPHIC CATHETER
    Manufacturer
    MILLAR INSTRUMENTS, INC.
    Date Cleared
    2000-03-01

    (120 days)

    Product Code
    DQO
    Regulation Number
    870.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    MILLAR INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Millar Angiographic catheter is designed to provide high fidelity pressure readings and deliver radiopaque contrast medium to selected sites in the vascular system.
    Device Description
    Not Found
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