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510(k) Data Aggregation

    K Number
    K242909
    Device Name
    FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors
    Manufacturer
    Edwards Lifesciences, LLC
    Date Cleared
    2025-03-21

    (178 days)

    Product Code
    DRS
    Regulation Number
    870.2850
    Why did this record match?
    Product Code :

    DRS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FloTrac sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output. They are intended to be used in adult patients. The FloTrac Jr sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output. The FloTrac Jr sensor is indicated for use in pediatric patients ≥ 12 years of age. The Acumen IQ sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output. They are intended to be used in adult patients. The VolumeView sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output.
    Device Description
    The FloTrac, Acumen IQ, and VolumeView sensors are constructed from two disposable pressure transducers that convert a physiological signal (or mechanical pressure) to an electrical signal that is transmitted through the cable to the patient monitor. The sensors have a straight, flow-through design in which fluid is passed directly across the pressure sensor. The sensors are comprised of a pressure sensitive silicon chip with two electrodes for excitation voltage and two electrodes for signal output. A polycarbonate housing with an integral stopcock at one end, and an integral flush device at the other end, encloses the sensors.
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    K Number
    K221782
    Device Name
    Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes
    Manufacturer
    Merit Medical Pte. Ltd.
    Date Cleared
    2023-03-17

    (269 days)

    Product Code
    DRS
    Regulation Number
    870.2850
    Why did this record match?
    Product Code :

    DRS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Meritrans ECO Reusable Pressure Transducer is intended to be coupled with a disposable dome kit for converting hemodynamic pressure waveforms via a piezoresistive bridge circuit into electrical signals for invasive blood pressure monitoring when connected to a patient monitor or recording device. The devices are intended for pediatric and adult patient populations.
    Device Description
    The Meritrans ECO Reusable Pressure Transducer is a non-invasive, reusable device used primarily for blood pressure monitoring. The housing assembly interfaces the pressure sensor assembly to the fluid channel of patient by coupling the transducer to the Meritrans ECO Disposable Dome. The fluid channel of patient is isolated from the pressure sensor by diaphragms. As the pressure signal of patient carried via the saline solution presses against the surface of transducer, the diaphragm is deflected, and the physiological pressure signal is transformed from the dome to the sensor of the reusable pressure transducer. Subsequently, the physiological pressure signal is transformed into electrical signal and displayed in a monitor that is connected via transducer interface cable. The Meritrans ECO Disposable Domes are disposable diaphragm domes which are coupled with the reusable transducer for invasive blood pressure monitoring. The disposable diaphragm dome has a transparent hemispherical hollow cavity. The domes have two ports; one port of the dome has a rotating Luer Lock fitting where the patient line is connected. Another port has an adaptor for connection to a pressurized IV fluid bag or an infusion pump. The disposable diaphragm dome has a diaphragm membrane that isolates the patient's fluid-filled system from the reusable transducer. For dome models with flush devices, an integral flow/flush device provides continuous flow of fluid to maintain catheter patency during the invasive blood pressure measurements.
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    K Number
    K172458
    Device Name
    HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
    Manufacturer
    Smiths Medical ASD, Inc.
    Date Cleared
    2017-11-09

    (87 days)

    Product Code
    DRS
    Regulation Number
    870.2850
    Why did this record match?
    Product Code :

    DRS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HemoDraw® Plus Closed Blood Sampling Set with LogiCal® Pressure Monitoring System is a hemodynamic pressure monitoring and blood sampling system designed to allow easy withdrawal of blood samples from an arterial or central venous pressure monitoring line while maintaining a completely closed system. The HemoDraw® Plus Closed Blood Sampling Set with TranStar® Pressure Monitoring System is a hemodynamic pressure monitoring and blood sampling system designed to allow easy withdrawal of blood samples from an arterial or central venous pressure monitoring line while maintaining a completely closed system.
    Device Description
    The HemoDraw® Plus Closed Blood Sampling Set with LogiCal® Pressure Monitoring System is a closed blood Sampling System designed to allow easy and safe withdrawal of blood samples from an arterial and central venous invasive pressure monitoring line. The LogiCal® Pressure Transducer mounting plate is intended for uses with the HemoDraw® Plus Closed Blood Sampling Set with LogiCal® Pressure Monitoring System. The LogiCal® monitoring set provides isolation between the fluid path connection to the patient and the transducer diaphragm. This set includes a flush device that is intended for use in invasive blood pressure measurements that require continuous flow to maintain catheter patency. The flush device provides a controlled and constant fluid infusion at a rate determined by the patient's blood pressure and the fluid source pressure. With a total fluid source pressure equal to 300mmHg, the flush device delivers an average flow rate of 3ml/hour. The device is supplied with a vented cap on the zeroing stopcock; this vented cap will allow air and saline to pass through and therefore can be kept in place when priming. To prevent the introduction of air into the system; after priming the vented cap should be replaced with a nonvented cap. This device is intended for single use only and is provided sterile and fluid path non-pyrogenic unless package is damaged or opened. The HemoDraw® Plus Closed Blood Sampling Set with TranStar® Pressure Monitoring System is a closed blood Sampling System designed to allow easy and safe withdrawal of blood samples from an arterial and venous invasive pressure monitoring line. The TranStar® Pressure Transducer mounting plate is intended for uses with the HemoDraw® Closed Blood Sampling Set with TranStar® Pressure Monitoring System. The TranStar® disposable monitoring set provides isolation between the fluid path connection to the patient and the transducer diaphragm. This set includes a flush device that is intended for use in invasive blood pressure measurements that require continuous flow to maintain catheter patency. The flush device provides a controlled and constant fluid infusion at a rate determined by the patient's blood pressure and the fluid source pressure. With a total fluid source pressure equal to 300mmHg, the flush device delivers an average flow rate of 3ml/hour. The device is supplied with a porous plug on the zeroing stopcock; this porous plug will allow air and saline to pass through and therefore can be kept in place when priming. To prevent the introduction of air into the system; after priming the porous plug should be replaced with a nonvented cap. This device is intended for single use only and is provided sterile and fluid path non-pyrogenic unless package is damaged or opened.
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    K Number
    K163172
    Device Name
    HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Date Cleared
    2017-05-24

    (191 days)

    Product Code
    DRS
    Regulation Number
    870.2850
    Why did this record match?
    Product Code :

    DRS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HemoDraw@ Plus Closed Blood Sampling Set with TranStar® Pressure Monitoring System is a hemodynamic pressure monitoring and blood sampling system designed to allow easy withdrawal of blood samples from an arterial or central venous pressure monitoring line while maintaining a completely closed system. This device is for use in adults only. The HemoDraw® Plus Closed Blood Sampling Set with LogiCal® Pressure Monitoring System is a hemodynamic pressure monitoring and blood sampling system designed to allow easy withdrawal of blood samples from an arterial or central venous pressure monitoring line while maintaining a completely closed system. This device is for use in adults only.
    Device Description
    The HemoDraw® Plus Closed Blood Sampling Set with LogiCal® Pressure Monitoring System is a closed blood Sampling System designed to allow easy and safe withdrawal of blood samples from an arterial and central venous invasive pressure monitoring line. The LogiCal® Pressure Transducer mounting plate is intended for uses with the HemoDraw® Plus Closed Blood Sampling Set with LogiCal® Pressure Monitoring System. The LogiCal® disposable monitoring set provides isolation between the fluid path connection to the patient and the transducer diaphragm. This set includes a flush device that is intended for use in invasive blood pressure measurements that require continuous flow to maintain catheter patency. The flush device provides a controlled and constant fluid infusion at a rate determined by the patient's blood pressure and the fluid source pressure. With a total fluid source pressure equal to 300mmHg, the flush device delivers an average flow rate of 3ml/hour. The device is supplied with a vented cap on the zeroing stopcock; this vented cap will allow air and saline to pass through and therefore can be kept in place when priming. To prevent the introduction of air into the system; after priming the vented cap should be replaced with a nonvented cap. This device is intended for single use only and is provided sterile and fluid path non-pyrogenic unless package is damaged or opened. The HemoDraw® Plus Closed Blood Sampling Set with TranStar® Pressure Monitoring System is a closed blood Sampling System designed to allow easy and safe withdrawal of blood samples from an arterial and venous invasive pressure monitoring line. The TranStar® Pressure Transducer mounting plate is intended for uses with the HemoDraw® Closed Blood Sampling Set with TranStar® Pressure Monitoring System. The LogiCal® disposable monitoring set provides isolation between the fluid path connection to the patient and the transducer diaphragm. This set includes a flush device that is intended for use in invasive blood pressure measurements that require continuous flow to maintain catheter patency. The flush device provides a controlled and constant fluid infusion at a rate determined by the patient's blood pressure and the fluid source pressure. With a total fluid source pressure equal to 300mmHg, the flush device delivers an average flow rate of 3ml/hour. The device is supplied with a porous plug on the zeroing stopcock; this porous plug will allow air and saline to pass through and therefore can be kept in place when priming. To prevent the introduction of air into the system; after priming the porous plug should be replaced with a nonvented cap. This device is intended for single use only and is provided sterile and fluid path non-pyrogenic unless package is damaged or opened.
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    K Number
    K161408
    Device Name
    Compass Cast and MAP
    Manufacturer
    CENTURION MEDICAL PRODUCTS CORPORATION
    Date Cleared
    2016-11-22

    (186 days)

    Product Code
    DRS, CON, DXG
    Regulation Number
    870.2850
    Why did this record match?
    Product Code :

    DRS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Compass Cast and MAP disposable pressure transducer system with integrated digital display and wireless transmission capability is intended for direct measurement and monitoring of physiologic pressure, including during the infusion of fluids and therapeutic and diagnostic agents.
    Device Description
    The Compass Cast and MAP disposable pressure transducer system with integrated digital display and wireless transmission capability is intended for direct measurement and monitoring of physiologic pressure, including during the infusion of fluids and therapeutic and diagnostic agents. The Compass CT and Compass CT Port are disposable, point-of-use pressure measurement and monitoring devices that incorporate a pressure transducer and an integrated pre-programmed diagnostic computer with liquid crystal display (LCD). The devices have a distal male luer fitting to connect to a needle or catheter, and a proximal female luer fitting that can be connected to accessory devices (e.g. syringes, caps, or infusion tubing). The devices measure the pressure via an embedded pressure sensor, internally convert changes in pressure into electrical currents, and then display the resulting pressure via the integrated LCD. The Compass CT Port has an additional, sealed proximal port through which commercially available guidewires can be inserted during pressure measurement. The Compass CT Port device is being modified to add wireless Bluetooth capability to the point-of-use Compass Cast device, in order to allow for optional display of acquired pressure data and information to a separate display monitor. The modified product will consist of two components that are packaged separately, the compass Cast (Subject Device) and MAP (Monitor Accessory Plug - Accessory). The Compass Cast (Subject Device) is a single-use, sterile pressure transducer that is physically identical to the predicate device Compass CT Port (510(k) K133624) with the exception of a slight modification to the main CT Port circuit board to accommodate the secondary Bluetooth radio board. All components and functionality of the main circuit board remain identical. The MAP (Accessory) is a non-sterile, reusable monitor accessory plug that receives a digital pressure signal from the Compass Cast and converts the digital pressure signal to an analog output that is identical to the analog output of a traditional wired pressure transducer. There are two versions of the MAP device: 1) Wireless Pressure Receiver - GE Monitor (CWMG001-5) 2) Wireless Pressure Receiver Philips Monitor (CWMP001-5)
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    K Number
    K152472
    Device Name
    Disposable Pressure Transducer
    Manufacturer
    ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD.
    Date Cleared
    2016-10-31

    (427 days)

    Product Code
    DRS
    Regulation Number
    870.2850
    Why did this record match?
    Product Code :

    DRS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Blood Pressure Transducer (DBPT) is intended for direct measurement and monitoring of fluid pressure.
    Device Description
    The Disposable Blood Pressure Transducer (DBPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The major components of the DBPT include the DBPT module that houses a ceramic, a luer connector with locking collar that can connect to an intravascular catheter, a transducer cable that can connect to a compatible pressure monitor and a stopcock for altering direction of fluid flow. The DBPT is provided sterile and for single use.
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    K Number
    K152980
    Device Name
    Flo Trac sensor, Volume View sensor
    Manufacturer
    Edwards Lifesciences, LLC
    Date Cleared
    2016-01-19

    (102 days)

    Product Code
    DRS
    Regulation Number
    870.2850
    Why did this record match?
    Product Code :

    DRS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FloTrac sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output. The VolumeView sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output.
    Device Description
    The Edwards Lifesciences FloTrac and VolumeView sensors are sterile, single use devices that monitors pressures when attached to pressure monitoring catheters. The FloTrac and VolumeView sensors are also capable of providing cardiac output measurements when connect to compatible Edwards monitoring systems.
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    K Number
    K151040
    Device Name
    Art-line Single channel blood pressure system, Art-line Double channel blood pressure system, Art-line Triple channel blood pressure system, IAP Monitoring Set with Disposable Transducer
    Manufacturer
    BIOMETRIX LTD.
    Date Cleared
    2015-09-04

    (137 days)

    Product Code
    DRS
    Regulation Number
    870.2850
    Why did this record match?
    Product Code :

    DRS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Art-Line™ Disposable Pressure Transducer Set (Art-Line™ DPT) is intended for measuring of the blood and/or intra-abdominal pressure of the critically ill patients. The blood pressure sensing is carried out by converting of the hemodynamic waves from a patient's intravasular catheter, through the integrated pressure transducer/sensor, into electrical signals which can be displayed on a monitoring equipment. The intra-abdominal pressure sensing is carried out in the same manner, however by converting of the physiological waves from the patient's inflated bladder. The device is for single and short term use.
    Device Description
    The Art-Line™ Disposable Pressure Transducer (Art-Line™ DPT ) set is a disposable pressure transducer device that interfaces between a catheter and a monitoring equipment by converting changes in pressure into electrical signals. The Art-Line™ DPT (see Table 1.) is offered in different configurations to fit physicians' needs: with one, two or three channel lines. Also it may be offered as a closed system which assist to prevent blood loss and minimize a cross contamination risk. The complete configuration may be pole or patient mounted. The set is sterile and non-pyrogenic.
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    K Number
    K133624
    Device Name
    COMPASS CT, COMPASS CT PORT
    Manufacturer
    MIRADOR BIOMEDICAL
    Date Cleared
    2014-04-18

    (143 days)

    Product Code
    DRS, DXG
    Regulation Number
    870.2850
    Why did this record match?
    Product Code :

    DRS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Compass™ CT disposable pressure transducer with integrated digital display is intended for direct measurement and monitoring of physiological pressure, including during the infusion of fluids and therapeutic and diagnostic agents. The Compass™ CT Port disposable pressure transducer with integrated digital display is intended for direct measurement and monitoring of physiological pressure, including during the infusion of fluids and therapeutic and diagnostic agents.
    Device Description
    The Compass CT and Compass CT Port are disposable, point-of-use pressure measurement and monitoring devices that incorporate a pressure transducer and an integrated pre-programmed diagnostic computer with liquid crystal display (LCD). The devices have a distal male luer fitting to connect to a needle or catheter, and a proximal female luer fitting that can be connected to accessory devices (e.g. syringes, caps, or infusion tubing). The devices measure the pressure via an embedded pressure sensor, internally convert changes in pressure into electrical currents, and then display the resulting pressure via the integrated LCD. The Compass CT Port has an additional, sealed proximal port through which commercially available guidewires can be inserted during pressure measurement.
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    K Number
    K123095
    Device Name
    MEDLINE BLOOD PRESSURE TRANSDUCER
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Date Cleared
    2013-05-08

    (218 days)

    Product Code
    DRS
    Regulation Number
    870.2850
    Why did this record match?
    Product Code :

    DRS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Medine Blood Pressure Transducer is intended for direct measurement and monitoring of blood pressure. This disposable transducer is intended for single use only. Indications for use include: - . Direct arterial blood pressure monitoring - central and peripheral - Pulmonary artery monitoring (PA distal) . - Venous pressure monitoring (RA Proximal) ● - Left atrial monitoring when used with an air eliminator . - Cardiac catheterization .
    Device Description
    Medline Blood Pressure Transducer
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