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510(k) Data Aggregation

    K Number
    K131770
    Device Name
    PRESSURE CONNECTING TUBE
    Manufacturer
    SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD
    Date Cleared
    2014-02-26

    (254 days)

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

    SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pressure Connecting Tube is for use during angiography procedures as a connecting line for the injection of liquid, such as radiopaque dye, saline, or other diagnostic fluids.
    Device Description
    The Pressure Connecting Tube is a sterile, single use device which can withstand injection pressures to 350~1200psi for use with power injectors to inject contrast media into implanted ports designed for use with power injectors. This device is designed, like other legally marked devices, for one end to connect to the fluid source (such as an angiographic syringe) and the other end to connect to the catheter. The fluid such as radipoaque dye, saline, or other diagnostic fluid is then injected from the syringe, through the connecting tube, into the catheter. The contrast, saline, or other diagnostic fluid is then injected from the syringe through the High Pressure Tube, into the catheter. According to the different pressure maintenance, the material of tube is PVC or PU, and the appearance is clear or braided.
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    K Number
    K102648
    Device Name
    ANT INFLATION DEVICE/ANT INFLATION DEVICE COMPACT PACK
    Manufacturer
    SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD
    Date Cleared
    2011-07-01

    (290 days)

    Product Code
    MAV
    Regulation Number
    870.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ANT Inflation Device is intended for use during vascular procedures in conjunction with interventional device such as balloon catheters to create and monitor pressure in the balloon catheter. The ANT Inflation Device Compact Pack: -ANT Inflation Device: See description above. -ANT Inflation Device Accessory Kit: The Accessory Kit is recommended for use during vascular procedures in conjunction and/or diagnostic device (e.g., balloon dilatation catheters, artherectorny devices, sent delivery systems, intravascular ultrasound devices.)
    Device Description
    ANT Inflation Device is a single-use, sterile device used in cardiovascular procedures to inflate and deflate balloon catheters. 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. Careful and controlled inflation is achieved by rotating the handle clockwise. During inflation a unique cam locking mechanism maintains pressure up to 30 ATM. ANT Inflation Device Accessory Compact Pack contains a hemostasis valve, a torque device, and a guide wire introducer. The hemostasis valve is designed to provide a port for interventional system. The guide wire introducer 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
    K091408
    Device Name
    DISPOSABLE PRESSURE TRANSDUCER
    Manufacturer
    SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD
    Date Cleared
    2009-08-18

    (98 days)

    Product Code
    DRS
    Regulation Number
    870.2850
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The disposable pressure transducer (DPT) is intended for direct measurement and monitoring of invasive blood pressure, intrauterine pressure, urine-dynamic pressure, compartmental (intramuscular) pressure and intracranial pressure.
    Device Description
    The proposed device, disposable pressure transducer (DPT), is an extravascular pressure transducer interfaces between an intravascular catheter and monitor by converting changes in pressure into electrical currents that can be impute into a compatible patient monitor. It is for single use; DPT mainly consists of a transducer which converting the pressure changes to electrical currents, a luer connector which can be connected to an intravascular catheter, a transducer cable that can connect to a compatible patient monitor and a stopcock for altering direction fluid flow.
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    K Number
    K072696
    Device Name
    ANT ANGIOGRAPHIC SYRINGES, MODEL(S) 100101,102,103,100201,202,203,204,100301,200101,201,202, 203,200301,101,102,202,301
    Manufacturer
    SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD
    Date Cleared
    2008-05-02

    (221 days)

    Product Code
    DXT
    Regulation Number
    870.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ANT Angiographic Syringes are syringes for the injection of contrast media or saline. This syringe is for single use with US legally marketed angiographic injectors.
    Device Description
    The applicant device of ANT Angiographic Syringes are plastic, single-use, disposable syringes to be offered in 10 mL, 12 mL, 20mL, 60mL, 60ml, 65ml, 100ml, 115 ml, 125 mL, 130ml, 140ml and 200mL sizes. The syringes will be offered made of polypropylene or PET- both materials, of which, are available in current legally marketed products. Variants: All variants include 7 series as followings: Series 1: Model 100101, Model 100103, Model 100103, Model 100202, Model 100202, Model 100203, Model 100204, Model 100301, Model 100302, Series 2: Model 200101, Model 200201, Model 200202, Model 200203, Model 200301, Series 3: Model 300101, Model 300102, Model 300202, Model 300301, Model 300302, Series 4: Model 400101, Series 5: Model 500101, Model 500102, Series 6: Model TR0012, Series 7: Model CS0010, Model CS0020, All 8 series follow same design principle, same material, and same intended use. The only differences are volume and the connection (nozzle) to different angiography injector from different manufacturer. The connection differs to fit with US legally Market Angiographic Injectors from company Medrad. The connector difference is only to fit the injector and does not affect the performance of the syringes.
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