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510(k) Data Aggregation
K Number
K242143Device Name
Angiography Injector
Manufacturer
Shandong INT Medical Instruments Co., Ltd.
Date Cleared
2024-12-23
(154 days)
Product Code
DXT
Regulation Number
870.1650Why did this record match?
Applicant Name (Manufacturer) :
Shandong INT Medical Instruments Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Angiography Injector is intended to aspirate and inject contrast media in the interventional procedure. It can also be used to inject fluids into, or withdraw fluids from the body.
Device Description
The Angiography Injector is intended to provide the function of aspirating and injecting contrast media in the interventional procedure. It can also be used to inject fluids into, or withdraw fluids from the body. The proposed device is intended for single use and is provided sterile using EO sterilization.
The Angiography Injector consists of six components: 1) Piston, 2) Plunger cap, 3) Push-button 4) Barrel, 5) Plunger and 6) Adapter (rotating or fixed). The proposed device is available in volume of 6mL, 8mL, 10mL and 12mL.
The primary package is blister package and plastic paper package. The blister package and plastic paper package all consist of PE film and Tyvek®2FS paper.
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