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510(k) Data Aggregation
K Number
K201720Device Name
LiPPS Analyzer, LiPPS Wire Pressure Guide Wire
Date Cleared
2021-02-18
(240 days)
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
Beijing Bywave Sensing Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
LiPPS™ Intravascular Pressure Sensing System is intended to be used in an environment like cathlab and for use in blood vessels, including coronary and peripheral vessels, to measure intravascular pressure during angiography and/or interventional procedures. Pressurements are obtained to provide hemodynamic information, such as fractional flow reserve, for the diagnosis and treatment of blood vessel diseases.
Device Description
The subject device LiPPSTM Intravascular Pressure Sensing System contains H2000 LiPPS™ Analyzer and LiPPS™ Wire Pressure Guide Wire.
The LiPPS™ Wire Pressure Guide Wire is used together with the H2000 LiPPS™ Analyzer in order to measure intravascular pressure. The LiPPS™ Wire contains an optical sensor and an optical fiber to induce the blood pressure and transmit signal. The LiPPS™ Wire can be connected to the analyzer through the companied handle (with an optical cable and an optical connector). The LiPPS™ Analyzer is an electronic signal processing and display units which can process signals received from the LiPPSTM Wire to display intravascular blood pressure and fractional flow reserve (FFR) values, and various connection cables. LiPPS™ Wire and companied handle (with an optical cable and an optical connector) are sterile, single-use devices. The LiPPS™ Analyzer and its accessories are reusable.
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