Data / Medical devices / China / Shanghai Achieva Medical Suzhou Co., Ltd.
Shanghai Achieva Medical Suzhou Co., Ltd.: FDA-registered device maker in Suzhou Jiangsu, China, 1 510(k) clearance
Shanghai Achieva Medical Suzhou Co., Ltd. is registered with the FDA (registration 3018070217) in Suzhou Jiangsu, China. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 16, 2026. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3018070217
- Address
- No.8 Zhongtian Alley, Suzhou Industrial Park,Suzhou Jiangsu, 215028, China No.133 Fangzhong Street, Suzhou Industrial Park,Suzhou, Jiangsu, 215028, China, Suzhou Jiangsu, China, 215028
- Owner or operator
- Shanghai Achieva Medical Suzhou Co., Ltd. (10095724)
- Roles
- Manufacturer
- First device listed
- April 20, 2026
- Registered through
- 2026
- Brand names listed
- DCwire Micro-guidewire
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Guide, Wire, Catheter, Neurovasculature | MOF | 2 | Manufacturer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 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 16, 2026 | K252122 | DCwire Micro-guidewire | MOF | Substantially Equivalent | Shanghai Achieva Medical Suzhou Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated March 16, 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.