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510(k) Data Aggregation
K Number
K153685Device Name
Sunmed Haemostatic Valves
Manufacturer
SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD.
Date Cleared
2016-10-13
(296 days)
Product Code
DQX, DTL
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SunmedTM Haemostatic Valves is intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional devices up to an external diameter of 7 Fr, 8 Fr or 9 Fr; The insertion tool facilitates introduction of guide wire through the haemostatic valves to reach the guiding catheter; The torquer provides a handle for easier manipulation of the guide wire when inserted into the proximal end of the guide wire.
Device Description
Hemostatic valves is composed of single Y connector, insertion tool and torquer. There are four models of the Hemostatic valves: Push-pull Y Connector, Screw Y Connector, Y click Connector and Double Screw Y Connector. Each single Y connector has two different structures: one is that the end of sideon is female luer; Another is that the end of sideon is the tubing and a stopcock. The Sunmed TM Hemostatic Valvesis designed to three external diameter of 7F, 8F, 9F for through different specifications of guide wire or catheter according to clinical need.
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K Number
K140356Device Name
SUMMED HIGH PRESSURE LINE
Manufacturer
SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD
Date Cleared
2015-03-20
(401 days)
Product Code
DQO, DOO
Regulation Number
870.1200Why did this record match?
Applicant Name (Manufacturer) :
SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sunmed™ High Pressure Line is used as a connecting line for injection of a contrast, saline or other diagnostic fluids (by connecting the female luer of high pressure with an angiographic syringe and connecting the male luer or rotating male luer of high pressure with the catheter) during coronary angiography procedures. This product is composed of female luer, male luer (including rotating male luer), and tubing and with or without caps.
Device Description
The Sunmed™ High Pressure Line is composed of female luer, male luer (including rotating male luer), and tubing and with or without caps.
The Sunmed™ High Pressure Line is used as a connecting line for injection of a contrast, saline or other diagnostic fluids (by connecting the female luer of high pressure with an angiographic syringe and connecting the male luer or rotating male luer of high pressure with the catheter) during coronary angiography procedures. This product is composed of female luer, male luer (including rotating male luer), and tubing and with or without caps.
The Sunmed™ High Pressure Line is single use and supplied sterile by Ethylene Oxide.
Package: Material: Dupont Tyvek package for medical use.
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K Number
K133795Device Name
SUMMED INFLATION DEVICE KIT
Manufacturer
SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD
Date Cleared
2014-12-12
(364 days)
Product Code
MAV
Regulation Number
870.1650Why did this record match?
Applicant Name (Manufacturer) :
SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD
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
K120119Device Name
SUNMED GUIDE WIRE
Manufacturer
SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD
Date Cleared
2012-05-11
(115 days)
Product Code
DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sunmed Guidewires are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion.
Device Description
Sunmed Guidewires are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and mav be used to reach and cross a target lesion.
The Sunmed Guide Wires are available in three versions with a variety of tips:
Stainless steel guide wire Hydrophilic coated quide wire PTFE (Teflon®) coated guide wires
The Seldinger technique is used with these quidewires.
The stainless steel guide wires are standard wires with various tip configurations. The guide wire construction consists of a safety wire, a core wire, and a wound spring for flexibility. The features that distinguish individual wires consist of the core type (fixed or moveable), a straight or "J" tip configuration, diameters and lengths.
The Hydrophilic coated guide wires are constructed from the stainless steel core wire, with varying core lengths and diameters for each design.
The PTFE (Teflon®) coated guide wires are also manufactured from stainless steel wire, with PTFE (Teflon®) coating, or Benzalkonium Heparin (BH) coating applied over the PTFE (Teflon®) coating.
These guide wires are radiodetectable and fluoroscopy may be used to confirm position.
These medical devices are single use and supplied sterile by EQ.
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