Data / Medical devices / France / Volta Medical
Volta Medical: FDA-registered device maker in Marseille Provence-Alpes-Cote d'Azur, France, 2 510(k) clearances
Volta Medical is registered with the FDA (registration 3017684005) in Marseille Provence-Alpes-Cote d'Azur, France. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated September 12, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017684005
- Address
- 65 avenue Jules Cantini, Marseille Provence-Alpes-Cote d'Azur, France, 13006
- Owner or operator
- Volta Medical (10078573)
- Roles
- Manufacturer
- First device listed
- November 16, 2025
- Registered through
- 2026
- Brand names listed
- Volta AF-Xplorer, Volta AF-Xplorer II
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | 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 |
|---|---|---|---|---|---|---|
| September 12, 2025 | K251518 | Volta AF-Xplorer II | DQK | Substantially Equivalent | Volta Medical | accessdata.fda.gov |
| May 9, 2025 | K243812 | Volta AF-Xplorer | DQK | Substantially Equivalent | Volta Medical | accessdata.fda.gov |
Compare with other makers
Updated September 12, 2025. 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.