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510(k) Data Aggregation
K Number
K232577Device Name
Radial Compression Device
Manufacturer
Ningbo DIZEGENS Medical Science Co., Ltd.
Date Cleared
2024-01-18
(146 days)
Product Code
DXC
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
Ningbo DIZEGENS Medical Science Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The radial compression device is designed to apply compression in order to achieve temporary hemostasis of the radial artery after a percutaneous transradial procedure.
Device Description
The Radial Compression Device (RC-001) is designed to promote hemostasis of the radial artery post percutaneous puncture. The radial compression device is fixed on the arm and the square pad of the device is pressed against the puncture site. The square cushion is adjusted to apply pressure and temporarily compress the puncture site of the radial artery to achieve rapid hemostasis. The product is primarily composed of a plate, turn cap, screw rod, hook and loop band, tapered cushion, and square cushion. The Radial Compression Device is available in one model, RC-001.
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K Number
K232388Device Name
High Pressure Tubing
Manufacturer
Ningbo DIZEGENS Medical Science Co., Ltd.
Date Cleared
2023-11-21
(104 days)
Product Code
DXT
Regulation Number
870.1650Why did this record match?
Applicant Name (Manufacturer) :
Ningbo DIZEGENS Medical Science Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
High Pressure Tubing is indicated for use in PTCA surgery to connect the angiographic catheter and the angiographic syringe to deliver contrast media.
Device Description
High Pressure Tubing is designed as a connecting line for injection of contrast media during coronary angiographic procedures. The device has a pressure resistance of 1200psi (8.3MPa); It is divided into two series according to the luer connector combination. ETM series consists of tubing and rotating male luer connecters, and the ETF series consists of tubing and rotating male luer connecter; The rotating male luer connector and female luer connector are made of polycarbonate and silica gel; The tubing is made of polyurethane, and the middle of the tube wall also contains nylon braided wire, which does not contact with outside. The High is for single use only, non-pyrogenic, sterilized by EO gas and the sterilization process is validated.
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