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510(k) Data Aggregation
K Number
K082439Device Name
DISPOSABLE ANGIOGRAPHIC SYRINGE, MODEL(S) CT-200-NE, CT-200-MA, CT-200+200-MA, CT-200-LF, CT -100-NE, CT-200NE, CT-50+CT
Manufacturer
SHANDONG WEIGAO MEDICAL POLYMER CO., LTD
Date Cleared
2009-03-23
(210 days)
Product Code
DXT
Regulation Number
870.1650Why did this record match?
Applicant Name (Manufacturer) :
SHANDONG WEIGAO MEDICAL POLYMER CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Disposable Angiographic 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 applicant device of Disposable Angiographic Syringe are plastic, single-use, disposable syringes to be offered in 50/50ml, 50/200ml, 60/60 mL, 60/100mL, 90ml,, 120 ml., 130 mL, 150 mL and 200mL sizes. The syringes will be offered made of PP and PETG both materials, of which, are available in current legally marketed products. All series follow same design principle, same material, and same intended use. The only differences are volume and the connection (nozzle) to different angiography injector from different manufacturer. The connection differs to fit with US legally Market Angiographic Injectors. The connector difference is only to fit the injector and does not affect the performance of the syringes.
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