K253407
- 510(k) number
- K253407
- Device name
- NeVa PV Thrombectomy Device
- Applicant
- Vesalio, Inc. CA · US
- Product code
- QEX — Coronary Mechanical Thrombectomy With Aspiration
- Decision date
- 2025-11-24
- Date received
- 2025-09-30
- Decision
- Unknown
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K253407.pdf
Official FDA record: K253407
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.