Data / Medical devices / Switzerland / Artiria Medical SA
Artiria Medical SA: FDA-registered device maker in Geneva Geneve, Switzerland, 1 510(k) clearance
Artiria Medical SA is registered with the FDA (registration 3030452144) in Geneva Geneve, Switzerland. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 24, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3030452144
- Address
- Campus Biotech Chemin Des Mines 15, Geneva Geneve, Switzerland, 1202
- Owner or operator
- Artiria Medical SA (10089862)
- Roles
- Manufacturer
- First device listed
- January 16, 2024
- Registered through
- 2026
- Brand names listed
- SmartGUIDE deflectable hydrophilic guide wire
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 |
|---|---|---|---|---|---|---|
| April 24, 2023 | K222690 | SmartGUIDE deflectable hydrophilic guidewire | MOF | Substantially Equivalent | Artiria Medical SA | accessdata.fda.gov |
Compare with other makers
Updated April 24, 2023. 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.