K251185
- 510(k) number
- K251185
- Device name
- Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020)
- Applicant
- Intervene CA · US
- Product code
- QEW — Peripheral Mechanical Thrombectomy With Aspiration
- Decision date
- 2025-10-22
- Date received
- 2025-04-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 4.2 MB · U.S. public domain
Also available from FDA: K251185.pdf
Official FDA record: K251185
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.