Data / Medical devices / China / Shanghai Microport Medical (group) Co., Ltd
Shanghai Microport Medical (group) Co., Ltd: FDA-registered device maker in Shanghai, China, 2 510(k) clearances
Shanghai Microport Medical (group) Co., Ltd is registered with the FDA (registration 3034695832) in Shanghai, China. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated April 7, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3034695832
- Address
- 1661 Zhangdong Road, ZJ Hi-Tech Park, Shanghai, China, 201203
- Owner or operator
- SHANGHAI MICROPORT MEDICAL (GROUP) CO., LTD (10058792)
- Roles
- Manufacturer
- First device listed
- July 26, 2023
- Registered through
- 2027
- Brand names listed
- Firefighter NC Pro PTCA Balloon Catheter, Firefighter Pro PTCA Balloon Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheters, Transluminal Coronary Angioplasty, Percutaneous | LOX | 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 |
|---|---|---|---|---|---|---|
| April 7, 2026 | K252116 | Firefighter Pro PTCA Balloon Catheter | LOX | Substantially Equivalent | Shanghai MicroPort Medical (Group) Co., Ltd. | accessdata.fda.gov |
| July 21, 2023 | K223189 | Firefighter NC Pro PTCA Balloon Catheter | LOX | Substantially Equivalent | Shanghai MicroPort Medical (Group) Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated April 7, 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.