K251070
- 510(k) number
- K251070
- Device name
- Akura Thrombectomy System
- Applicant
- Akura Medical CA · US
- Product code
- QEW — Peripheral Mechanical Thrombectomy With Aspiration
- Decision date
- 2025-11-25
- Date received
- 2025-04-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K251070.pdf
Official FDA record: K251070
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.