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510(k) Data Aggregation
K Number
K170014Device Name
High Pressure Tubing
Manufacturer
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD.
Date Cleared
2017-10-06
(276 days)
Product Code
DXT
Regulation Number
870.1650Why did this record match?
Applicant Name (Manufacturer) :
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The High Pressure Tubing is indicated for use as a connecting line for injection of contrast media or saline during coronary angiographic procedures.
Device Description
The High Pressure Tubing is a sterile, single use device which can withstand injection pressure to 1200psi. The High Pressure Tubing is composed of tubing with connector at each end. The connector is a female-male combination and rotating adapter. The High Pressure Tubing is supplied sterile by Ethylene Oxide and disposable device. The material of tube is PU with polvamides liner, and the appearance is braided.
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K Number
K170027Device Name
Inflation Device
Manufacturer
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD.
Date Cleared
2017-10-06
(276 days)
Product Code
MAV
Regulation Number
870.1650Why did this record match?
Applicant Name (Manufacturer) :
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD.
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
K170024Device Name
Y-Connector Kit
Manufacturer
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD.
Date Cleared
2017-10-03
(273 days)
Product Code
DTL, DQX
Regulation Number
870.4290Why did this record match?
Applicant Name (Manufacturer) :
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Y-Connector hemostasis valve is intended to minimize blood loss during the introduction, withdrawal and use of devices that have an outer diameter of 8F catheter during diagnostic and interventional procedures.
The Insertion Tool facilitates introduction of a guidewire through the Y-Connector and into the guiding catheter.
The Torque Device attaches to guidewires and provides a handle to assist in manipulation of the guidewire.
Device Description
The Y-connector kit is single use disposable device. It including Y connector, Insertion tool and torque device. It is mainly use for PTCA or PTA procedures to create the entrance and minimize blood loss when intervention device are inserted into the human vascular system.
The Y connector with a rotating luer lock, a sidearm and a hemostasis valve that is designed to provide a port for interventional system. The seal of hemostasis valve can be opened by pushing the switch cap, and closed by releasing switch cap.
The insertion tool is used to facilitate placement of a guide wire tip through the Y connector.
The torque device is designed to hold the guide wire and provide a handle for manipulating, so the doctor can control the guide wire to the right position.
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K Number
K170025Device Name
Angiography Syringe
Manufacturer
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD.
Date Cleared
2017-10-03
(273 days)
Product Code
DXT
Regulation Number
870.1650Why did this record match?
Applicant Name (Manufacturer) :
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Angiography syringe is used to inject contrast media into the heart, great vessels, and coronary arteries during angiographic procedures.
Device Description
The Angiography Syringe are plastic , single-use, disposable syringes to be offered in 6ml, 8ml, 10ml, 12ml size. As manual control syringe, each configuration includes bilateral, external finger rings located on the proximal barrel shaft. The proximal thumb rings located on the plunger, in tandem with the external finger rings on the barrel, allows for single handed movement to create aspiration and/or expulsion of fluids. The angiography syringe has two tip fitting: fixed adapter and rotating adapter
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