Data / Medical devices / Catheters, Transluminal Coronary Angioplasty, Percutaneous / China
FDA-registered makers of Catheters, Transluminal Coronary Angioplasty, Percutaneous in China: 9 establishments
9 establishments in China are registered with the FDA to make Catheters, Transluminal Coronary Angioplasty, Percutaneous (product code LOX). 9 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Product code
- LOX
- Country
- China
Makers of Catheters, Transluminal Coronary Angioplasty, Percutaneous in China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Brosmed Medical Co.,ltd | Dongguan Guangdong, China | Manufacturer, Specification developer | 5 | April 11, 2023 | 0 | 0 | 0 | api.fda.gov |
| OrbusNeich Medical (Shenzhen) Co., Ltd. | SHENZHEN Guangdong, China | Complaint file establishment, Manufacturer | 5 | August 16, 2024 | 0 | 0 | 0 | api.fda.gov |
| Kossel Medtech (suzhou) Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 3 | January 7, 2022 | 0 | 0 | 0 | api.fda.gov |
| Shanghai Microport Medical (group) Co., Ltd | Shanghai, China | Manufacturer | 2 | April 7, 2026 | 0 | 0 | 0 | api.fda.gov |
| Shanghai Microport Medical (group) Co., Ltd | Shanghai, China | Manufacturer, Specification developer | 2 | April 7, 2026 | 0 | 0 | 0 | api.fda.gov |
| Shanghai Microport Medical (group) Co., Ltd | Shanghai, China | Manufacturer | 2 | April 7, 2026 | 0 | 0 | 0 | api.fda.gov |
| Sino Medical Sciences Technology Inc. | Tianjin, China | Manufacturer | 2 | February 15, 2023 | 0 | 0 | 0 | api.fda.gov |
| Dongguan TT Medical, Inc. | Dongguan Guangdong, China | Manufacturer | 1 | June 29, 2023 | 0 | 0 | 0 | api.fda.gov |
| Lepu Medical Technology (beijing) Co., Ltd | Beijing, China | Manufacturer | 1 | August 13, 2013 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.