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510(k) Data Aggregation
K Number
K152906Device Name
Disposable High Pressure Injector Syringe
Manufacturer
WUXI YUSHOU MEDICAL APPLICANCES CO., LTD
Date Cleared
2016-11-22
(418 days)
Product Code
DXT
Regulation Number
870.1650Why did this record match?
Applicant Name (Manufacturer) :
WUXI YUSHOU MEDICAL APPLICANCES CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Disposable High Pressure Injector Syringe is intended for the injection of contrast media or saline. This syringe is for single use with US legally marketed angiographic injectors.
Device Description
The product has two types: one type is composed of one or several syringes and one or several accessories. The accessories include connecting tube and medicine aspirator (punctured medicine aspirator and tubular medicine aspirator); the other type is composed of individual accessory; the syringe is composed of barrel, plunger, piston or plunger cap. The connecting tube has one-way and multi-way. One-way connecting tube is composed of locking connector, tubing, female conical fitting, nozzle cap, protective cap or one-way valve; multi-way connecting tube is composed of multi-way connector, locking connector, tubing, female conical fitting, nozzle cap, protective cap, one-way valve or puncture.
Maximum rated pressure for the Disposable High Pressure Injector Syringe is either 300psi (2.07MPa) or 1200psi (8.3MPa). The rated pressure for each models are listed in the following Models and Combinations Table.
The aspirator has tubular medicine aspirator and punctured medicine aspirator. Punctured medicine aspirator has plastic pin.
Product packaging: Primary package is heat-sealed by Tyvek paper and PS blister.
The following configurations of various syringes and accessories are available than are in compatible with market available injectors from Medrad, Liebel-Flarsheim, Acist or Nemoto.
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K Number
K130212Device Name
SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGE
Manufacturer
WUXI YUSHOU MEDICAL APPLICANCES CO., LTD
Date Cleared
2013-11-20
(295 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
WUXI YUSHOU MEDICAL APPLICANCES CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Safety Hypodermic Needle With/Without Syringe device is intended for use in the aspiration of fluids for medical purposes. The Safety Hypodernic Needle With/Without Syringe is compatible for use with standard her lock syringes. Additionally, after withdraval of the needle from the body, the attached can be manually activated to cover the needle immediately after use to minimize risk of accidental needle-stick.
Device Description
The Safety Hypodermic Needle With/Without Syringe consists of a hypodermic needle with a hinged safety sheath attached to the connector hub with or without an attached hypodermic syringe. This device features a hinged safety sheath attached to the needle hub. The safety sheath which are simultaneously activated when manually pressed over the needle immediately after use and just prior to disposal to minimize the possibility of sharps injury. The safety sheath is activated with a one-handed operation by pressing the sheath either by finger or thumb, or by surface activation. The locking mechanisms are positioned within the center and proximal end of the Sheath. The hinge feature allows the medical practitioner to flexibly adjust the sheath to its desired position for use.
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K Number
K130230Device Name
STERILE PISTON HYPODERMIC SYRINGES (WITH/WITHOUT NEEDLE), HYPODERMIC NEEDLES
Manufacturer
WUXI YUSHOU MEDICAL APPLICANCES CO., LTD
Date Cleared
2013-11-20
(295 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
WUXI YUSHOU MEDICAL APPLICANCES CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sterile Piston Hypodermic Syringes (With/Without Needed for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the fennector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from the body.
The hypodermic needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe.
Device Description
The piston syringe is a device intended for medical purposes, consisting of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male Luer Slip/Lock connector (nozzle) for attaching the female Luer connector (hub) of a hypodermic single lumen needle, or for attaching other devices with a female Luer. The syringe is sterilized by EtO gas. And it is a Non-Pyrogenic and single use device. The mainly raw materials are PP, PE and rubber.
The Hypodermic Needle is a single lumen needle, designed for use with syringes and injection devices for general purpose fluid injection. The needle is sterilized by EtO gas. and it is a Non-Pyrogenic and single use device. The mainly raw materials are PP and stainless steel.
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K Number
K053519Device Name
SAFETY SYRINGE
Manufacturer
WUXI YUSHOU MEDICAL APPLICANCES CO., LTD
Date Cleared
2006-08-11
(235 days)
Product Code
MEG
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
WUXI YUSHOU MEDICAL APPLICANCES CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device's primary intended use is general purpose injection of fluids into, or withdrawal of fluids from the body, below the surface of the skin except for phlebotomy. Its secondary intended use is to retract inside the safety barrel, contain the contaminated needle and aid in the prevention of accidental needle stick injuries.
Device Description
The Safety Syringe per (21 CFR § 880.5860) is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle.
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