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FDA 510(k)

LiPPS Analyzer, LiPPS Wire Pressure Guide Wire

K-Number: K201720 · 2021-02-18

ApplicantBeijing Bywave Sensing Medical Technology Co., Ltd.
Decision Date2021-02-18
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LiPPS Analyzer, LiPPS Wire Pressure Guide Wire is a medical device manufactured by Beijing Bywave Sensing Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-02-18 under approval number K201720. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LiPPS Analyzer, LiPPS Wire Pressure Guide Wire?

LiPPS Analyzer, LiPPS Wire Pressure Guide Wire is a medical device that received FDA 510(k) clearance on 2021-02-18. It is manufactured by Beijing Bywave Sensing Medical Technology Co., Ltd.. The 510(k) number is K201720.

When was LiPPS Analyzer, LiPPS Wire Pressure Guide Wire approved by the FDA?

LiPPS Analyzer, LiPPS Wire Pressure Guide Wire received FDA 510(k) clearance on 2021-02-18, under approval number K201720.

What company makes LiPPS Analyzer, LiPPS Wire Pressure Guide Wire?

LiPPS Analyzer, LiPPS Wire Pressure Guide Wire is manufactured by Beijing Bywave Sensing Medical Technology Co., Ltd..

What is the FDA product code for LiPPS Analyzer, LiPPS Wire Pressure Guide Wire?

The FDA product code for LiPPS Analyzer, LiPPS Wire Pressure Guide Wire is DQX.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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