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510(k) Data Aggregation

    K Number
    K220773
    Device Name
    Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC3205P)
    Manufacturer
    Medtronic Vascular
    Date Cleared
    2022-04-13

    (28 days)

    Product Code
    MAV
    Regulation Number
    870.1650
    Why did this record match?
    Product Code :

    MAV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Everest 20cc Inflation Device/Survival Kit is to be used to facilitate the use of catheters and guide wires during interventional procedures. The Everest 20cc Inflation Device is designed to inflate/deflate balloon catheters as well as to monitor pressure within the balloon. The Y/Tri-Adapter with Hemostasis Valve is designed to be used on a guiding catheter or dilatation catheter to control backbleeding and to provide a port for introduction of fluids into the interventional system. The Guide Wire Insertion Tool is designed to facilitate placement of a guide wire tip through the Y/ Tri-Adanter and into the wire lumen of an interventional catheter. The Guide Wire Steering Handle is designed to hold a small diameter guide wire and provide a handle for manipulating the wire.
    Device Description
    Medtronic's Everest™ Disposable Inflation Device is a sterile 20cc inflation device with a locking mechanism that is operated via a trigger. Normally, the locking mechanism is engaged. Once the trigger is pulled back, the locking mechanism is released and the piston can be manually manipulated. The Everest™ 20 Device is outfitted with a manometer with measuring pressures ranging from vacuum to 20 bars in 0.5bar increments. The Everest™ 30 Device is outfitted with a manometer with measuring pressure reading from vacuum to 30 bars in 1 bar increments. A high pressure connecting tube with a male rotating adapter and a disposable 3-way stopcock are also included to aid in preparation of the device. When purchased as a "Survival Kit", the package includes a Y-/ Tri-Adapter with hemostasis valve, a Guide Wire Insertion Tool and a Steering Handle.
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    K Number
    K170027
    Device Name
    Inflation Device
    Manufacturer
    SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD.
    Date Cleared
    2017-10-06

    (276 days)

    Product Code
    MAV
    Regulation Number
    870.1650
    Why did this record match?
    Product Code :

    MAV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The inflation device is intended to be used in PTCA or PTA procedures to create and monitor pressure in the balloon and to deflate the balloon dilatation catheter.
    Device Description
    The inflation device consists of barrel, threaded plunger assemble with a handle, a trigger, pressure gauge, an outer shell assembly that retains the internal components, and a pressure connecting tubing with rotating adapter. Also enclosed is a stopcock to aid in preparation and use of device. The inflation device is 20 mL disposable device capable of producing a maximum pressure of 30 atm. The inflation device is sterilized by EO.
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    K Number
    K162272
    Device Name
    Fluent inflation device
    Manufacturer
    VASCULAR SOLUTIONS, INC.
    Date Cleared
    2016-10-20

    (69 days)

    Product Code
    MAV
    Regulation Number
    870.1650
    Why did this record match?
    Product Code :

    MAV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fluent inflation device is intended for use during cardiovascular procedures to create, maintain and monitor pressure in the balloon catheter.
    Device Description
    The Fluent inflation device consists of a barrel with a plunger, locking button, rotating handle, manometer, and high pressure tube with a rotating luer lock. The manometer is graduated between vacuum and 30 atm.
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    K Number
    K153038
    Device Name
    Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit
    Manufacturer
    MEDTRONIC, INC.
    Date Cleared
    2016-04-13

    (177 days)

    Product Code
    MAV
    Regulation Number
    870.1650
    Why did this record match?
    Product Code :

    MAV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Everest 20cc Inflation Device/ Survival Kit is to be used to facilitate the use of catheters and guide wires during interventional procedures. The Everest 20cc Inflation Device is designed to be used to inflate/ deflate balloon catheters as well as to monitor pressure within the balloon. The Y/Tri-Adaptor with Hemostasis Valve is designed to be used on a guiding catheter or dilatation catheter to control backbleeding and to provide a port for introduction of fluids into the interventional system. The Guide Wire Insertion Tool is designed to facilitate placement of a guide wire tip through the Y/ Tri-Adapter and into the wire lumen of an interventional catheter. The Guide Wire Steering Handle is designed to hold a small diameter guide wire and provide a handle for manipulating the wire.
    Device Description
    Medtronic's Everest™ Disposable Inflation Device is a sterile 20cc inflation device with a locking mechanism that is operated via a trigger. Normally, the locking mechanism is engaged. Once the trigger is pulled back, the locking mechanism is released and the piston can be manually manipulated. The Everest™ 20 Device is outfitted with a manometer with measuring pressures ranging from vacuum to 20 bars in 0.5bar increments. The Everest™ 30 Device is outfitted with a manometer with measuring pressure reading from vacuum to 30bars in 1 bar increments. A high pressure connecting tube with a male rotating adapter and a disposable 3-way stopcock are also included to aid in preparation of the device. When purchased as a “Survival Kit", the package includes a Y-/ Tri- Adapter with hemostasis valve, a Guide Wire Insertion Tool and a Steering Handle.
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    K Number
    K153672
    Device Name
    basixTOUCH40 Inflation Syringe
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Date Cleared
    2016-01-20

    (30 days)

    Product Code
    MAV
    Regulation Number
    870.1650
    Why did this record match?
    Product Code :

    MAV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The basixTOUCH40 Inflation Syringe is used to inflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon.
    Device Description
    The basixTOUCH40TM Inflation Syringe by Merit Medical is a 30mL disposable device with a threaded plunger assembly, a flexible high pressure extension tube. The basixTOUCH40TM is designed to generate positive and negative pressure, and monitor positive pressures over a range of zero to +40ATM/BAR (zero to 588 PSI).
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    K Number
    K152387
    Device Name
    Fluent Inflation Device
    Manufacturer
    VASCULAR SOLUTIONS, INC.
    Date Cleared
    2015-12-18

    (116 days)

    Product Code
    MAV
    Regulation Number
    870.1650
    Why did this record match?
    Product Code :

    MAV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fluent inflation device is intended for use during cardiovascular procedures to create, maintain and monitor pressure in the balloon catheter. The sidearm extension tubing is intended to provide a sterile fluid pathway between two devices.
    Device Description
    The Fluent inflation device consists of a barrel with a plunger, locking button, rotating handle, manometer, and high pressure tube with a rotating male luer lock. The manometer is graduated between vacuum and 30 atm. The extension tubing is a plastic tube with plastic luer lock connector hubs (one male and one female) at either end. It is available in 25 cm and 50 cm lengths.
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    K Number
    K140943
    Device Name
    MASTRO PLUS BALLOON IN-DEFLATION DEVICE
    Manufacturer
    BEIJING DEMAX MEDICAL TECHNOLOGY CO., LTD.
    Date Cleared
    2015-03-05

    (325 days)

    Product Code
    MAV
    Regulation Number
    870.1650
    Why did this record match?
    Product Code :

    MAV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Balloon In-deflation device is used for the inflation of a balloon dilatation catheter, to dilate the vessel or implant a stent.
    Device Description
    The Balloon In-deflation Device is a 20ml or 30ml disposable device capable of producing a maximum pressure of 30atm/bars. It is fitted with a threaded plunger, a flexible high pressure extension tube, and a three-way high pressure stopcock. The luminescent pressure gauge with adjustable angle allows physician to read and monitor more easily in clinical environment. The product is designed under ergonomic principle that could be handled comfortably, easily and securely. The balloon in-deflation device mainly composes of four parts, injecting system (syringe), pressure gauge and extension tube, 3way stopcock, respectively. The syringe consists of a screw type plunger and a locking lever, by rotating palm grip to control the plunger; the pressure gauge is to measure pressure and the extension tube is to connect catheters. The angle of the pressure gauge can be re-adjusted during the procedure.
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    K Number
    K143522
    Device Name
    Presto Inflation Device
    Manufacturer
    C.R. BARD, INC.
    Date Cleared
    2015-01-12

    (31 days)

    Product Code
    MAV
    Regulation Number
    870.1650
    Why did this record match?
    Product Code :

    MAV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Presto™ Inflation Device is indicated for use with angioplasty balloon dilatation catheters to create and monitor the pressure in the angioplasty balloon dilatation catheter and to deflate the angioplasty balloon dilatation catheter.
    Device Description
    The Presto™ Inflation Device is an ultra high pressure, large volume inflation device used to inflate, monitor pressure, and deflate angioplasty balloon dilatation catheters. It is a onepiece, 30 mL disposable inflation device rated for 40 atm with a lever-lock design that controls the piston, a manometer, and a high-pressure connecting tube with a male Luer rotating adapter. Also enclosed is a high-pressure 3-way stopcock to aid in preparation and use of the device. The manometer measures pressures ranging from 0 atm up to 40 atm in 1 atm increments. The accuracy of the manometer has been determined to be within ±1.6 ATM. These products are not made with natural rubber latex.
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    K Number
    K133795
    Device Name
    SUMMED INFLATION DEVICE KIT
    Manufacturer
    SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD
    Date Cleared
    2014-12-12

    (364 days)

    Product Code
    MAV
    Regulation Number
    870.1650
    Why did this record match?
    Product Code :

    MAV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sunmed The Inflation Device is a set of accessorial device. It is composed of an inflation device, and may be composed of a stopcock and a hemostatic valve. The inflation device is intended for use in PTCA or PTA procedures to create and monitor pressure (by connecting the rotating male luer of inflation device with the balloon catheter's female luer) in the balloon and to deflate the balloon. The hemostatic valve is recommended for use during PTCA or PTA procedures in conjunction and/or diagnostic device (e.g. balloon dilatation catheters).Stopcock is used to release and purge any trapped air (if used).
    Device Description
    The Sunmed The Inflation Device is a set of accessorial device. It is composed of an inflation device, and may be composed of a stopcock and a hemostatic valve. The inflation device is 30ml disposable device capable of producing a maximum pressure of 40ATM. Pressure can be monitored via a pressure gauge. The manually operation of the device is achieved by the manipulation of a large handle to drive a piston housed within the body of the device. Hemostatic valve is a single Y connector, and may be composed of an insertion tool, and a torquer. The hemostasis valve is designed to provide a port for interventional system. The insertion tool is used to facilitate placement of a guide wire tip through the hemostasis valve. The torque device is designed to hold the guide wire and provide a handle for manipulating.
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    K Number
    K140745
    Device Name
    ENCORE 26 ADVANTAGE KIT
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Date Cleared
    2014-04-17

    (23 days)

    Product Code
    MAV
    Regulation Number
    870.1650
    Why did this record match?
    Product Code :

    MAV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Encore 26 Advantage Kit is a kit of sterile disposable devices intended of ruse as accessories for percutaneous coronary angiography (PTCA) procedures. They allow for balloon inflation and wire control. Encore™ 26 Inflation Device: indicated for use with balloon dilatation catheters to create and monitor pressure in the balloon, and to deflate the balloon. Gateway™ Plus Y-Adaptor: used for providing hemostasis around balloon dilatation catheters, guidewires and other therapeutic devices during general intravascular procedures. Torque Device: used for guidewire manipulation during general intravascular procedures. Insertion Tool: used to facilitate the introduction of a quidewire during general intravascular procedures.
    Device Description
    The Encore™ 26 Advantage Kit is a Kit of sterile disposable devices intended for use as accessories and percutaneous coronary angiography (PTCA) procedures. They allow for balloon inflation and wire control.
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