Data / Medical devices / China / Pulnovo Medical (wuxi) Co., Ltd.
Pulnovo Medical (wuxi) Co., Ltd.: FDA-registered device maker in Wuxi Jiangsu, China, 1 510(k) clearance
Pulnovo Medical (wuxi) Co., Ltd. is registered with the FDA (registration 3041086754) in Wuxi Jiangsu, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 8, 2024. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3041086754
- Address
- 3rd Floor, Building D17, No.1719-17 Huishan Avenue and 3rd Floor, Building D11, No.1719-11 Huishan Avenue Huis, Wuxi Jiangsu, China, 214000
- Owner or operator
- Pulnovo Medical (Wuxi) Co., Ltd. (10095366)
- Roles
- Manufacturer
- First device listed
- March 4, 2026
- Registered through
- 2026
- Brand names listed
- PFlexi
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Introducer, Catheter | DYB | 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 |
|---|---|---|---|---|---|---|
| November 8, 2024 | K242756 | Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090) | DYB | Substantially Equivalent | Pulnovo Medical (Wuxi) Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated November 8, 2024. 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.