Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Beijing Bywave Sensing Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-02-18 under 510(k) 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. The listed applicant is Beijing Bywave Sensing Medical Technology Co., Ltd.. The 510(k) number is K201720.

When did LiPPS Analyzer, LiPPS Wire Pressure Guide Wire receive FDA 510(k) clearance?

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

Who is the listed applicant for LiPPS Analyzer, LiPPS Wire Pressure Guide Wire?

The FDA 510(k) record lists Beijing Bywave Sensing Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: DQX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253667Accoat Guide WireSp Medical A/SK261640Merit MAK Nitinol/Gold-Tungsten Guide WireMerit Medical Ireland , Ltd.K254137InQwire Amplatz Guide WireMerit Medical Ireland, Ltd.K260544FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40FMD Co., Ltd.K253746Enroute 0.014'' Transcarotid GuidewireLake Region MedicalK253262EmeryGlide™ (EG18008901)Nano4imaging GmbH

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.

↑