K253975
- 510(k) number
- K253975
- Device name
- Radical 6F Access Catheter
- Applicant
- Maduro Medical, Inc. CA · US
- Product code
- QJP — Catheter, Percutaneous, Neurovasculature
- Decision date
- 2026-04-09
- Date received
- 2025-12-11
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K253975.pdf
Official FDA record: K253975
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.