K251312
- 510(k) number
- K251312
- Device name
- Vesalio Peripheral System
- Applicant
- Vesalio, Inc. CA · US
- Product code
- QEZ — Aspiration Thrombectomy Catheter
- Decision date
- 2025-10-24
- Date received
- 2025-04-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251312.pdf
Official FDA record: K251312
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.