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510(k) Data Aggregation
K Number
K242248Device Name
Introducer Sheath Kits
Manufacturer
Beijing Demax Medical Technology Co., Ltd.
Date Cleared
2024-08-22
(22 days)
Product Code
DYB
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
Beijing Demax Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Introducer Sheath Kits are intended for use to facilitate the introduction of guide wires, catheters and other accessory medical devices through the skin into a vern or artery and minimize blood loss associated with such introduction.
Device Description
Not Found
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K Number
K222184Device Name
Introducer Sheath Kits
Manufacturer
Beijing Demax Medical Technology Co., Ltd.
Date Cleared
2023-02-21
(214 days)
Product Code
DYB
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
Beijing Demax Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Introducer Sheath Kits are intended for use to facilitate the introduction of guide wires, catheters and other accessory medical devices through the skin into a vern or artery and minimize blood loss associated with such introduction.
Device Description
Not Found
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K Number
K222182Device Name
Radial Artery Compression Tourniquets
Manufacturer
Beijing Demax Medical Technology Co., Ltd.
Date Cleared
2023-01-04
(166 days)
Product Code
DXC
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
Beijing Demax Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Radial Artery Compression Tourniquet is designed for temporary hemostasis of radial artery post percutaneous puncture.
Device Description
Radial Artery Compression Tourniquets
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K Number
K140943Device Name
MASTRO PLUS BALLOON IN-DEFLATION DEVICE
Manufacturer
BEIJING DEMAX MEDICAL TECHNOLOGY CO., LTD.
Date Cleared
2015-03-05
(325 days)
Product Code
MAV
Regulation Number
870.1650Why did this record match?
Applicant Name (Manufacturer) :
BEIJING DEMAX MEDICAL TECHNOLOGY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Balloon In-deflation device is used for the inflation of a balloon dilatation catheter, to dilate the vessel or implant a stent.
Device Description
The Balloon In-deflation Device is a 20ml or 30ml disposable device capable of producing a maximum pressure of 30atm/bars. It is fitted with a threaded plunger, a flexible high pressure extension tube, and a three-way high pressure stopcock. The luminescent pressure gauge with adjustable angle allows physician to read and monitor more easily in clinical environment. The product is designed under ergonomic principle that could be handled comfortably, easily and securely. The balloon in-deflation device mainly composes of four parts, injecting system (syringe), pressure gauge and extension tube, 3way stopcock, respectively. The syringe consists of a screw type plunger and a locking lever, by rotating palm grip to control the plunger; the pressure gauge is to measure pressure and the extension tube is to connect catheters. The angle of the pressure gauge can be re-adjusted during the procedure.
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