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Lepu Medical Technology (beijing) Co., Ltd: FDA-registered device maker in Beijing, China, 5 510(k) clearances

Name: Lepu Medical Technology (beijing) Co., Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Lepu Medical Technology (beijing) Co., Ltd is registered with the FDA (registration 3008002401) in Beijing, China. It lists 7 device types. The FDA files 5 510(k) clearances under its listings, the newest dated March 2, 2018. 1 recall event names it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3008002401
Address: No.37 Chaoqian Rd. Changping District, Beijing, China, 102200
Owner or operator: Lepu Medical Technology (Beijing) Co., Ltd (10038811)
Roles: Manufacturer
First device listed: December 11, 2013
Registered through: 2026
Brand names listed: Brilliant Introducer Kits, Guidewire Introducer, Guidewire Torquer, Hoper, Inflation Device, Shoocin Introducer Kit, ULTRASKIN, Vasc Band and more

Devices it lists

Device	Product code	Class	Role	Source
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	DTL	2	Manufacturer	accessdata.fda.gov
Catheters, Transluminal Coronary Angioplasty, Percutaneous	LOX	2	Manufacturer	accessdata.fda.gov
Clamp, Vascular	DXC	2	Manufacturer	accessdata.fda.gov
Introducer, Catheter	DYB	2	Manufacturer	accessdata.fda.gov
Syringe, Balloon Inflation, Exempt	PTM	2	Manufacturer	accessdata.fda.gov
Wire, Guide, Catheter	DQX	2	Manufacturer	accessdata.fda.gov
Wire, Guide, Catheter, Exempt	PTL	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 2, 2018	K172331	Type I, Type II, Type III, Type IV	DYB	Unknown	Lepu Medical Technology (Beijing) Co., Ltd.	accessdata.fda.gov
October 5, 2017	K172099	Shoocin Introducer Kit	DYB	Substantially Equivalent	Lepu Medical Technology (Beijing) Co., Ltd.	accessdata.fda.gov
January 21, 2015	K141707	ULTRASKIN HYDROPHILIC GUIDE WIRE	DQX	Substantially Equivalent	Lepu Medical Technology (Beijing) Co., Ltd.	accessdata.fda.gov
October 23, 2014	K142359	Vasc Band hemostat	DXC	Substantially Equivalent	Lepu Medical Technology (Beijing) Co., Ltd.	accessdata.fda.gov
August 13, 2013	K123473	HOPER PTCA BALLOON CATHETER	LOX	Substantially Equivalent	Lepu Medical Technology (Beijing) Co., Ltd.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
April 26, 2021	87737	Class I	Completed	Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for qualitative detection of IgM and/or IgG antibodies to SARS-CoV-2 in human serum, plasma and venipuncture whole blood f	Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) is not authorized, cleared, or approved for marketing and/or distribution in the U.S.	accessdata.fda.gov

Compare with other makers

Updated March 2, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.