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510(k) Data Aggregation

    K Number
    K131966
    Device Name
    TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION CATHETER SYSTEM
    Manufacturer
    TWIN STAR MEDICAL, INC.
    Date Cleared
    2014-02-07

    (224 days)

    Product Code
    LXC
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    TWIN STAR MEDICAL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Twin Star Extremity Compartment Monitor and Fluid Collection System (ECM-III) is intended for the immediate or continuous measurement of intracompartmental pressures and/or the withdrawal of fluid for subsequent analysis. The measured compartmental pressures can be used as an aid in the diagnosis of compartment syndrome.
    Device Description
    The Twin Star Extremity Compartment Monitor and Fluid Collection System (ECM-III) consists of four major components; an Introducer, a Pressure Monitoring and Fluid Collection (PMFC) Catheter, a Fluid Collection (FC) Catheter, and a Compartment Pressure Monitor. The Introducer consists of tear-away plastic sheath placed over a stainless steel trocar. The Introducer provides an access to the targeted muscle compartment to facilitate the placement of the indwelling Pressure Monitoring Fluid Collection / Fluid Collection catheter. The indwelling Catheter is designed to monitor intramuscular compartment pressure as well as provide a means to sample interstitial fluid for laboratory analysis. The indwelling Catheter is designed for use up to 24 hours. The Twin Star Extremity Compartment Monitor and Fluid Collection System (ECM-III) provides a means of displaying the intracompartmental pressure.
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    K Number
    K090961
    Device Name
    TWIN STAR COMPARTMENT PRESSURE MONITOR AND FLUID COLLECTION CATHETER SYSTEM (CMS-II)
    Manufacturer
    TWIN STAR MEDICAL, INC.
    Date Cleared
    2009-06-12

    (67 days)

    Product Code
    LXC
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    TWIN STAR MEDICAL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Twin Star Compartment Pressure Monitor and Fluid Collection Catheter System (CMS-II) is intended for the immediate or continuous measurement of intracompartmental pressures and/or the withdrawal of fluid for subsequent analysis. The measured compartmental pressures can be used as an aid in the diagnosis of compartment syndrome.
    Device Description
    The Twin Star Compartment Pressure Monitoring and Fluid Collection Catheter System (CMS-II) consists of four major components; an Introducer, a Pressure Monitoring and Fluid Collection (PMFC) Catheter, a Fluid Collection (FC) Catheter, and a Compartment Pressure Monitor. The Introducer consists of tear-away plastic sheath placed over a stainless steel trocar. compartment to facilitate the placement of the indwelling Pressure Monitoring Fluid Collection / Fluid Collection catheter. The indwelling Catheter is designed to monitor intramuscular compartment pressure as well as provide a means to sample interstitial fluid for laboratory analysis. The indwelling Catheter is designed for use up to 24 hours. The Twin Star Compartment Pressure Monitoring provides a means of displaying the intracompartmental pressure.
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    K Number
    K060963
    Device Name
    TWIN STAR COMPARTMENT PRESSURE MONITORING AND FLUID COLLECTION MONITOR (CMS MONITOR)
    Manufacturer
    TWIN STAR MEDICAL
    Date Cleared
    2006-06-06

    (60 days)

    Product Code
    LXC
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    TWIN STAR MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Twin Star Compartment Pressure Monitoring and Fluid Collection Monitor (CMS Monitor) is intended for the measurement and monitoring of intracompartmental pressures and the withdrawal of fluid for subsequent analysis. The measured compartmental pressures can be used as an aid in the diagnosis of compartment syndrome. The CMS Monitor is intended to be used in conjunction with the Twin Star Compartment Pressure Monitoring and Fluid Collection Catheter (CMS Catheter).
    Device Description
    The Twin Star Compartment Pressure Monitoring and Fluid Collection (CMS) Monitor displays and records pressure as measured by the Twin Star Compartment Pressure Monitoring and Fluid Collection Catheter (CMS Catheter). The Twin Star CMS Catheter has been previously cleared by 510k notification. The multi-task CSM Monitor consists of a single housing unit that incorporates a vacuum pump, an infusion pump and a pressure monitor with visual display and user interface. The CMS Monitor provides the necessary functions required by the CMS Catheter. In addition to monitoring pressure, the CMS Monitor provides a very low volume fluid infusion to maintain the CMS Catheter's pressure lumen patency and a vacuum to the second lumen for fluid collection; both infusion and vacuum are required for the functional operation of the CMS Catheter.
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    K Number
    K041771
    Device Name
    TWIN STAR COMPARTMENT SYNDROME PRESSURE MONITORING AND FLUID COLLECTION CATHETER SYSTEM
    Manufacturer
    TWIN STAR MEDICAL, INC.
    Date Cleared
    2004-09-14

    (76 days)

    Product Code
    LXC
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    TWIN STAR MEDICAL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Twin Star Compartment Pressure Monitoring and Fluid Collection Catheter System is intended for the immediate or continuous measurement of intracompartmental pressure and for the withdrawal of fluid for subsequent analysis. The measured pressures and the withdrawn fluid serve as an aid in the diagnosis of compartment syndrome.
    Device Description
    The Twin Star Compartment Pressure Monitoring and Fluid Collection Catheter System Consists of two major components i.e., an Introducer and an indwelling Catheter. The Introducer consists of a plastic sheath placed over a stainless steel trocar. The Introducer provides an access to the targeted muscle compartment to facilitate the placement of the indwelling Monitoring and Fluid Collection Catheter. The indwelling Catheter is designed to measure intramuscular compartment pressure as well as provide a means to collect a sample interstitial fluid for laboratory analysis. The indwelling Catheter is designed for use up to 24 hours. The Twin Star Compartment Pressure Monitoring and Fluid Collection Catheter System is designed to be used with currently marketed equipment including a vacuum pump, infusion pump, pressure transducer and monitor.
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