K251518
- 510(k) number
- K251518
- Device name
- Volta AF-Xplorer II
- Applicant
- Volta Medical FR
- Product code
- DQK — Computer, Diagnostic, Programmable
- Decision date
- 2025-09-12
- Date received
- 2025-05-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K251518.pdf
Official FDA record: K251518
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.