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510(k) Data Aggregation
K Number
K172694Device Name
Sterile Disposable Syringes
Manufacturer
Date Cleared
2018-07-06
(302 days)
Product Code
Regulation Number
870.1650Why did this record match?
Applicant Name (Manufacturer) :
Shenyang MasTech Medical Device Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Sterile Disposable Syringes are intended for the injection of contrast media or saline, they shall be used with an U.S legally marketed angiographic injector.
Device Description
The proposed devices are available in packs, which may include different configuration of syringes and accessories. 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, compatibilities are shown in Table 1. The connecting tubes, which is used to connect the syringe and the catheter. The tubes are available in three configurations, which are straight tube, Type T tube and spiral tube. The different between these tubes is tube shape, which is available in straight shape for straight tube, spiral shape for spiral tube and T shape for T tube. The Type T tube is available in a various specifications to connect different model of syringe. J shape tube, which is used to draw contrast media/ saline into the syringe barrel. Spikes, which are used to draw contrast media/saline into the syringe barrel.
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