LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD

FDA Device Registration & Listing · Beijing, CN · Registration 3008002401

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008002401
FEI Number
3008002401
Entity Name
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD
City/State/Country
Beijing, CN
Establishment Address
No.37 Chaoqian Rd., Changping District, Beijing 102200, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Lepu Medical Technology (Beijing) Co., Ltd (Owner Number: 10038811)
Owner / Operator Contact Address
No.37 Chaoqian Rd.,, Changping District, Beijing, CN-BJ 102200, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

ULTRASKIN Guidewire Introducer Guidewire Torquer Shoocin Introducer Kit Hoper Y-Hemostasis Valve Vasc Band Brilliant Introducer Kits Inflation Device

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2018-05-03
PTL Wire, Guide, Catheter, Exempt Cardiovascular Class 2 870.1330 2018-05-11
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2018-05-11
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2013-12-11
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2018-05-11
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2014-11-18
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2023-06-07
PTM Syringe, Balloon Inflation, Exempt Cardiovascular Class 2 870.1650 2018-05-03

Official Correspondent

Ling Ge

US Agent Details

Xu Wen Email: info@believe-med.com Phone: (443) 8968583

Related Public Records

Same Entity

Lepu Medical Technology (Beijing) Co., Ltd
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3018312328 LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD Beijing, CN
3011564431 Beijing Target Medical Technologies Inc. Beijing, CN

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K150445 Asahi Intecc Co., Ltd. ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV) 2015-06-30
K082922 Lake Region Mfg., Inc. FREEWAY AND RAILRUNNER GUIDEWIRES 2008-12-09
K890207 E-Z-Em, Inc. INTERVENTIONAL PRODUCTS - GUIDE WIRES 1989-05-31
K992169 Advanced Cardiovascular Systems, Inc. ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE 1999-10-28
K012534 Advanced Cardiovascular Systems, Inc. HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING 2002-01-24

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0030-2009 Boston Scientific Corporation 2
Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-2009 Boston Scientific Corporation 2
Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0783-2020 Abbott Medical 2
Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020 Abbott Medical 2
Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.
Z-0030-04 N/A 2
Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071011

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008002401. Last updated year: 2026. Please use registration number 3008002401 when referencing this establishment in official correspondence.
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