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510(k) Data Aggregation
K Number
K170279Device Name
Disposable High Pressure Syringe
Manufacturer
Union Medical Shenzhen Co., Ltd.
Date Cleared
2017-12-12
(316 days)
Product Code
DXT
Regulation Number
870.1650Why did this record match?
Applicant Name (Manufacturer) :
Union Medical Shenzhen Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable High Pressure Syringe is intended for the injection of contrast media or saline. This syringe is for single use and it shall be used with US legally marketed angiographic injectors.
Device Description
The Disposable High Pressure Syringe is available in packs, which may include different configurations of syringes and accessories, the accessories include connector tube, Quick fill tube and Spike.
The syringes are plastic, disposable syringes, which are available in various models and configurations. They are intended to be used with an U.S. legally marketed angiography injector.
The connector tube is used to connect the syringe and the catheter. They are also available in three configurations, which are WLP Series tube with one syringe connector (used with single shot syringe), WLT Series tube and WLM Series tube with two syringe connectors (used with dual shot syringe). The three connector tubes can withstand maximum pressure of 350psi.
The Quick Fill Tube and the Spike is used to draw drug into the syringe.
The proposed devices are intended to be used with an U.S. legally marketed angiography injector; compatibilities are shown in Table 1.
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