Data / Medical devices / China / Lepu Medical Technology (beijing) Co., Ltd
Lepu Medical Technology (beijing) Co., Ltd: FDA-registered device maker in Beijing, China, 1 510(k) clearance
Lepu Medical Technology (beijing) Co., Ltd is registered with the FDA (registration 3018312328) in Beijing, China. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 23, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018312328
- Address
- Building 5 No. 21 Courtyard, Panlong West Road Pinggu District, Beijing, China, 101204
- Owner or operator
- Lepu Medical Technology (Beijing) Co., Ltd (10038811)
- Roles
- Manufacturer
- First device listed
- November 18, 2014
- Registered through
- 2026
- Brand names listed
- Guidewire Introducer, Guidewire Torquer, Inflation Device, Vasc Band, Y-Hemostasis Valve
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | 2 | Manufacturer | accessdata.fda.gov |
| Clamp, Vascular | DXC | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Balloon Inflation, Exempt | PTM | 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 |
|---|---|---|---|---|---|---|
| October 23, 2014 | K142359 | Vasc Band hemostat | DXC | Substantially Equivalent | Lepu Medical Technology (Beijing) Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- All makers of Syringe, Balloon Inflation, Exempt
- All makers of Clamp, Vascular
- All makers of Wire, Guide, Catheter, Exempt
Updated October 23, 2014. 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.