K253730
- 510(k) number
- K253730
- Device name
- RoVo Mechanical Thrombectomy System
- Applicant
- Verge Medical, Inc. CA · US
- Product code
- QEW — Peripheral Mechanical Thrombectomy With Aspiration
- Decision date
- 2026-01-21
- Date received
- 2025-11-24
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K253730.pdf
Official FDA record: K253730
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.